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NCT05560477 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
A Phase 1 study of Meniscus Tear, sponsored by University of Cincinnati.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 3
- Study locations
NCT05560477: Recruiting Phase 1 study of Meniscus Tear, sponsored by University of Cincinnati.
NCT05560477 is a Phase 1 study of Meniscus Tear that is actively recruiting participants, run by University of Cincinnati. The registered enrollment target is 74 participants, below the 82-participant average among 6 other Meniscus Tear trials with a reported enrollment target (10% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05560477, a Phase 1 study of Meniscus Tear, is actively recruiting participants, sponsored by University of Cincinnati.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study.
Primary Outcome
Presence or absence of healing assessed via MRI
Conditions Studied
Interventions
- DRUG AM3101
- DRUG Saline Placebo
Study Locations (3)
Ohio
- University of Cincinnati - Cincinnati
- University Hospitals Cleveland Medical Center - Cleveland
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT05560477 shows while recruiting
NCT05560477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 82-participant average among 6 other Meniscus Tear trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Meniscus Tear appearing as the primary indexed condition, and to 2 interventions - of which AM3101 is the first listed.
NCT05560477 reports a single indexed study location in Ohio, Oregon.
Frequently Asked Questions
What is clinical trial NCT05560477 about?
NCT05560477 is a clinical study titled "Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing". The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center ...
What is the current status of trial NCT05560477?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2023-04-26. Estimated completion is 2027-06.
What conditions does trial NCT05560477 study?
This clinical trial studies the following conditions: Meniscus Tear.
What interventions are being tested in trial NCT05560477?
The interventions under investigation include: AM3101 (DRUG), Saline Placebo (DRUG).
Who is sponsoring clinical trial NCT05560477?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05560477 being conducted?
This trial has 3 study locations across Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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