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NCT Number: NCT04660721

A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.

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Key information

Conditions

Hemostasis Cardiovascular Diseases Embolism and Thrombosis General Surgery Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, Austria

Loading trial locations.

About this study

Many products have been developed as adjuncts to hemostasis in bleeding situations where traditional methods such as suture, clips or energy-based coagulation are ineffective or impractical.

Many products are not as effective in the presence of active and/or brisk bleeding since the lack of sufficient adhesion strength allows forceful bleeding to simply "float" the products away from the bleeding tissue, prior to the achievement of full hemostasis.

The Study investigates a new product, sFilm-FS, aimed to help the control of body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients (males or females) aged ≥ 18 years old.
  • Patients requiring elective open hepatic surgery.
  • Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure.
  • Patients understanding the nature of the study and providing their informed consent prior to participation.
  • Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol.

Intra-operative inclusion criteria:

  • Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).

Exclusion criteria

  • Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
  • Patients with a severe coagulopathy defined as INR > 2.0.
  • Patients with platelet count <50,000 x109 PLT/L at the screening.
  • Patients admitted to trauma surgery.
  • Transplant patients due to fulminant hepatic failure.
  • Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator.
  • Patients with anesthesia risk judged to be higher than ASA3 by the Investigator.
  • Patients with at least one of the following concomitant conditions: severe co-morbid conditions known to pose a high risk for surgery and adequate recovery (i.e., liver cirrhosis with Child-Pugh score B or C, cholestasis, heart diseases), immunodeficiency diseases, blood clotting disorders, any conditions known to effect wound healing (i.e., collagen vascular disease), known or current alcohol or drug abusers.
  • Patients suffering from claustrophobia.
  • Patients with implanted or embedded metal objects, prostheses, pacemaker, or fragments in the head or body that would present a risk during the MRI scanning procedure or have worked with ferrous metals either as a vocation or hobby or following trauma (i.e., sheet metal workers, welders, or machinists) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field.
  • Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents.
  • Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
  • Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.
  • Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.

Intra-operative exclusion criteria:

  • Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
  • Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair.
  • Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
  • Patients having an active local infection in the anatomic surgical area.
  • Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
  • Patients with bleeding site in or near to foramina in bone.

Treatment and study plan

sFilm-FS

Combination Product

sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.

TACHOSIL®

Combination Product

TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Primary outcomes

  1. To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)

  2. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by measuring Systolic Blood Pressure (mmHg)

  3. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular)

  4. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (pH)

  5. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Hemoglobin (g/L))

  6. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen.

    Time frame: Last Follow-Up Visit (Visit 9)

    Safety will be assessed from randomization of patients until the last follow-up visit by Measuring plasma levels of antibodies against human fibrinogen, by performing a screening assay using bridging ELISA based on polyclonal antibodies against human fibrinogen, which was developed with a sensitivity of 1000 ng/ml. Patients whose results were above 1000ng/ml control were considered positive.

  7. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by measuring Diastolic Blood Pressure (mmHg)

  8. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by measuring Heart Rate (beats/minute)

  9. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by measuring Respiratory Rate (breaths/minute)

  10. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by measuring Body Temperature (°C)

  11. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Specific Gravity (g/L))

  12. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Presence of Glucose)

  13. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin Concentration (g/L))

  14. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin (pg))

  15. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Corpuscular Volume (fL))

  16. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Red Blood Cell (10^12cells/L))

  17. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (White Blood Cell (10^9cells/L))

  18. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Platelet (10^9cells/L))

  19. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Fibrinogen (g/L))

  20. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (D-Dimer (microg/mL))

  21. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Erythrocyte Sedimentation Rate (mm/hr))

  22. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (C-Reactive Protein (mg/dL))

  23. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Blood Urea Nitrogen (mmol/L))

  24. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Creatinine (micromol/L))

  25. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Uric Acid (micromol/L))

  26. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Bilirubin (micromol/L))

  27. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Lactate Dehydrogenase (microkat/L))

  28. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Oxaloacetic Transaminase/Aspartate Aminotransferase (microkat/L))

  29. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Pyruvic Transaminase/Alanine Aminotransferase (microkat/L))

  30. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Gamma-GT (microkat/L))

  31. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Sodium (mmol/L))

  32. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Calcium (mmol/L))

  33. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Phosphorous (mmol/L))

  34. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Glucose (mmol/L))

  35. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Albumin (g/L))

  36. To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

    Time frame: From visit 1 to visit 9 (an average of 6.5 months)

    Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Protein (g/L))

Secondary outcomes

  1. To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS

    Time frame: Day of surgery

    Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure

  2. To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS

    Time frame: Day of surgery

    Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application)

  3. To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis

    Time frame: Day of surgery

    Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes

  4. To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure

    Time frame: Day of surgery

    Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time)

  5. To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure.

    Time frame: From surgery, up to 6 months

    Incidence of transfusion requirements in the 6 months follow-up period

Sponsors and collaborators

Lead sponsor

Sealantium Medical Ltd.

Industry

Collaborators

  • Home Medics Consulting Ltd.
  • Sintesi Research Srl

Registry information

Official study title

A Phase I/II, Randomized, Prospective, Controlled, Multi-center, Open-label, Two-arm Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Liver Bleeding During Elective Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2020
Registry last updated
Mar 21, 2025

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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