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NCT06041321 · ClinicalTrials.gov registry record · NA
Novel Bioactive Sleeve on Pain and PROMs
A NA study of Meniscus Tear, sponsored by Northwell Health.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06041321: Recruiting NA study of Meniscus Tear, sponsored by Northwell Health.
NCT06041321 is a NA study of Meniscus Tear that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 100 participants, above the 77-participant average among 6 other Meniscus Tear trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06041321, a NA study of Meniscus Tear, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.
Primary Outcome
Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to pain. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Conditions Studied
Interventions
- DEVICE Reparel Sleeve
- DEVICE Placebo Sleeve
Study Locations (1)
New York
- Orlin and Cohen Orthopedics - Woodbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-12-06 |
| Est. Completion | 2027-10 |
| Phase | NA |
What NCT06041321 shows while recruiting
NCT06041321 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 6 other Meniscus Tear trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Meniscus Tear appearing as the primary indexed condition, and to 2 interventions - of which Reparel Sleeve is the first listed.
NCT06041321 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06041321 about?
NCT06041321 is a clinical study titled "Novel Bioactive Sleeve on Pain and PROMs". A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.
What is the current status of trial NCT06041321?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-12-06. Estimated completion is 2027-10.
What conditions does trial NCT06041321 study?
This clinical trial studies the following conditions: Meniscus Tear.
What interventions are being tested in trial NCT06041321?
The interventions under investigation include: Reparel Sleeve (DEVICE), Placebo Sleeve (DEVICE).
Who is sponsoring clinical trial NCT06041321?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06041321 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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