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Active, Not Recruiting

NCT Number: NCT04511364

CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP

The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.

To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).

Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
  • Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
  • Subject is capable of giving written informed consent to participate in the study.

Exclusion criteria

  • Subject was withdrawn from CONFIRM.
  • Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.

Treatment and study plan

Clinical imaging is performed during the 24 and 60 month follow-up visits

Other

X-ray and DXA scan

Primary outcomes

  1. Change in DXA score at 24 months

    Time frame: 24 months

    Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.

Secondary outcomes

  1. Change in DXA score at 60 months

    Time frame: 60 months

    Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.

  2. Hip fracture incidence

    Time frame: 60 months

    The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.

  3. Radiologic bone formation

    Time frame: 60 months

    Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.

Other outcomes

  1. Safety evaluation

    Time frame: 60 months

    The incidence of all serious adverse events during follow-up determined to be at least possibly related to the procedure and/or device through 60 months post-AGN1 LOEP treatment.

Sponsors and collaborators

Lead sponsor

AgNovos Healthcare, LLC

Industry

Registry information

Official study title

Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2020
Registry last updated
Jan 31, 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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