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Completed

NCT Number: NCT05987033

Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.

Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Hospitalier de Luxembourg

Luxembourg, 1210

About this study

This is a prospective, single arm, monocentric first-in-human PoC study in adult patients, suffering from a distal radius fracture, treated during the surgical intervention with NVDX3, an osteogenic implant from human allogeneic origin.

As per standard of care, patients with DRF are followed up to 3 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 12 months post-implant surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients within the age range of ≥18 years to ≤80 years.
  • Patient diagnosed with DRF with confirmed:
  • Classification AO/ATO: C2 and C3 - Intra-articular & multifragmentation.
  • Estimated volume of the targeted bone void should not exceed 5cc.
  • Availability of diagnostic AP and LAT X-ray or CT scan.
  • Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.
  • Patient fulfills criteria for undergoing a surgical intervention.
  • Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.

Exclusion criteria

  • Open DRF or closed DRF with increased infection risk.
  • Injury to the median nerve.
  • Previous fracture of the target distal radius.
  • Documented disease limiting mobility and functional assessments (eg. Grip strength test).
  • Dependency on crutches or any comparable walking aids.
  • Patient is overweight, has a BMI ≥35.
  • Presence of clinically significant infection at the target implant site or systemic infection.
  • History of allergic reaction or any anticipated hypersensitivity to any of the anticipated:
  • Osteosynthesis materials (PEEK plate and screws).
  • Anesthetic agents.
  • Components of the NVDX3 implant.
  • Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.
  • Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.
  • Presence of an active tumor.
  • Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism.
  • Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy.
  • Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening.
  • Any history of experimental therapy with another investigational drug within 60 days prior to screening.
  • Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study.
  • Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results.
  • Patient with historically elevated radiation exposure levels that could in the opinion of the investigator have introduced unacceptable radiation risks for the patient, when being accumulated with the radiological examinations planned in this study.

Treatment and study plan

NVDX3

Drug

NVDX3 is implanted during a single surgical intervention.

Primary outcomes

  1. Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs

    Time frame: Between the beginning of the implant surgery (IS) and 12 months post-IS

    Number of participants with serious treatment-emergent adverse events (TEAEs) and NVDX3-related TEAEs

Secondary outcomes

  1. Safety: Serious TEAEs and NVDX3-related TEAEs

    Time frame: Between the beginning of IS and 6 weeks post-IS

    Number of participants with serious TEAEs and NVDX3-related TEAEs

  2. Safety: Serious TEAEs and NVDX3-related TEAEs

    Time frame: Beyond 6 weeks post-IS till 12 months post-IS

    Number of participants with serious TEAEs and NVDX3-related TEAEs

  3. Safety: TEAEs

    Time frame: Between the beginning of IS and 6 weeks post-IS Beyond 6 weeks post-IS till 12 months post-IS Between the beginning of IS and 12 months post-IS

    Number of participants with TEAEs

  4. Safety: Related and Unexpected TEAEs and Serious TEAEs

    Time frame: Between the beginning of IS and 12 months post-IS

    Number of participants with related and unexpected TEAEs and serious TEAEs

  5. Safety: TEAEs of Special Interest

    Time frame: Between the beginning of IS and 12 months post-IS

    Number of participants with TEAEs of Special Interest

  6. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation

    Time frame: At 3 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation

  7. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Formation

    Time frame: At 12 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation

  8. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union

    Time frame: At 3 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union

  9. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Union

    Time frame: At 12 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union

  10. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling

    Time frame: At 3 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling

  11. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Bone Remodelling

    Time frame: At 12 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling

    The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing.

  12. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score

    Time frame: At 3 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score

    The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing.

  13. Efficacy: Radiological Assessments on Computed Tomography (CT) Data - Evaluation of Total Extended Lane and Sandhu Score

    Time frame: At 12 months post-IS

    Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score

    The total eLSS score is the sum of three individual components: bone formation, defined as filling of the longitudinal gap, is scored from 0-5 points; bone union, defined as filling of the transverse gap, is scored from 0-5 points; and bone remodeling, defined as the appearance of continuous bone architecture (trabecula and cortex) within the new bone formed in the defect, is scored from 0-2. The eLSS therefore has a score range of 0-12 points, with higher scores indicating better bone healing.

  14. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation

    Time frame: At 2 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation

  15. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation

    Time frame: At 6 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation

  16. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation

    Time frame: At 3 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation

  17. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation

    Time frame: At 6 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation

  18. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Formation

    Time frame: At 12 months post-IS

    Radiological assessments on X-ray data using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation

  19. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union

    Time frame: At 2 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union

  20. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union

    Time frame: At 6 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union

  21. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union

    Time frame: At 3 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union

  22. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union

    Time frame: At 6 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union

  23. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Union

    Time frame: At 12 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone union

  24. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling

    Time frame: At 2 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling

  25. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling

    Time frame: At 6 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling

  26. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling

    Time frame: At 3 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling

  27. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling

    Time frame: At 6 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling

  28. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Bone Remodelling

    Time frame: At 12 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone remodelling

  29. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score

    Time frame: At 2 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score

    The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.

  30. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score

    Time frame: At 6 weeks post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score

    The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.

  31. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score

    Time frame: At 3 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score

    The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.

  32. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score

    Time frame: At 6 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score

    The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.

  33. Efficacy: Radiological Assessments on X-ray Data - Evaluation of Total Extended Lane and Sandhu Score

    Time frame: At 12 months post-IS

    Radiological assessments on X-ray using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of Total extended Lane and Sandhu Score

    The eLSS was also applied for assessment of X-ray images to support findings from CT images reflecting radiological healing over the 12-month study period. As described above, the total eLSS score is the sum of three individual components: bone formation (0-5 points), bone union (0-5 points), and bone remodeling, (0-2 points). The eLSS therefore has a score range of 0-12 points with higher scores indicating better bone healing.

  34. Efficacy: Clinical Assessments - Grip Strength

    Time frame: At 2 weeks post-IS

    Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)

  35. Efficacy: Clinical Assessments - Grip Strength

    Time frame: At 6 weeks post-IS

    Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)

  36. Efficacy: Clinical Assessments - Grip Strength

    Time frame: At 3 months post-IS

    Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)

  37. Efficacy: Clinical Assessments - Grip Strength

    Time frame: At 6 months post-IS

    Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)

  38. Efficacy: Clinical Assessments - Grip Strength

    Time frame: At 12 months post-IS

    Grip strength measure with a hydraulic hand dynamometer, difference from normal (Fraction of the Strength on the Uninjured Side)

  39. Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)

    Time frame: At Hospital Discharge

    Physician Reported Modified Mayo Wrist Score, total score The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.

  40. Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)

    Time frame: At 2 weeks post-IS

    Physician Reported Modified Mayo Wrist Score, total score

    The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.

  41. Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)

    Time frame: At 6 weeks post-IS

    Physician Reported Modified Mayo Wrist Score, total score

    The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.

  42. Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)

    Time frame: At 3 months post-IS

    Physician Reported Modified Mayo Wrist Score, total score

    The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.

  43. Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)

    Time frame: At 6 months post-IS

    Physician Reported Modified Mayo Wrist Score, total score

    The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.

  44. Efficacy: Clinical Assessments - Modified Mayo Wrist Score (MMWS)

    Time frame: At 12 months post-IS

    Physician Reported Modified Mayo Wrist Score, total score

    The physician-reported MMWS is a clinical assessment that evaluates dimensions of pain, patient satisfaction, range of motion, and grip strength each on a scale of 0-25 points. The total score ranges from 0-100 points with higher scores indicating a better result.

  45. Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)

    Time frame: At 2 weeks post-IS

    PRWE total score

    The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.

  46. Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)

    Time frame: At 6 weeks post-IS

    PRWE total score

    The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.

  47. Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)

    Time frame: At 3 months post-IS

    PRWE total score

    The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.

  48. Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)

    Time frame: At 6 months post-IS

    PRWE total score

    The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.

  49. Efficacy: Clinical Assessments - Patient-rated Wrist Evaluation (PRWE)

    Time frame: At 12 months post-IS

    PRWE total score

    The PRWE consists of two subscales: the pain subscale, which contains 5 items each rated from 0 (no pain) to 10 (worst pain ever) for a total of 50 points, and the function subscale, which contains 10 items divided into specific activities (6 items) and usual activities (4 items), each rated on a scale from 0 (no difficulty) to 10 (so difficult it cannot be done). The function score is divided by 2 and added to the pain score for a total score ranges of 0-100, with lower scores indicating less wrist pain and disability.

  50. Efficacy: NRS-pain

    Time frame: At hospital discharge

    NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).

  51. Efficacy: NRS-pain

    Time frame: At 2 weeks post-IS

    NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).

  52. Efficacy: NRS-pain

    Time frame: At 6 weeks post-IS

    NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).

  53. Efficacy: NRS-pain

    Time frame: At 3 months post-IS

    NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).

  54. Efficacy: NRS-pain

    Time frame: At 6 months post-IS

    NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).

  55. Efficacy: NRS-pain

    Time frame: At 12 months post-IS

    NRS-pain score. NRS-pain is a patient-reported instrument for evaluating pain in clinical studies. Pain at time of the patient's visit at site was assessed on a numerical scale from 0 (no pain) to 10 (worst pain imaginable).

Sponsors and collaborators

Lead sponsor

Novadip Biosciences

Industry

Registry information

Official study title

A First-in-human Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Distal Radius Fractures in Adults.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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