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NCT05882812 · ClinicalTrials.gov registry record · Phase 2
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
A Phase 2 study of Osteoarthritis, Knee and Arthritis, sponsored by ZetrOZ.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 3
- Study locations
NCT05882812: Completed Phase 2 study of Osteoarthritis, Knee and Arthritis, sponsored by ZetrOZ.
NCT05882812 is a Phase 2 study of Osteoarthritis, Knee and Arthritis that has completed, run by ZetrOZ. The registered enrollment target is 200 participants, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (60% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05882812, a Phase 2 study of Osteoarthritis, Knee and Arthritis, has completed, sponsored by ZetrOZ.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over an 8-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.
Primary Outcome
Change in the self described pain units on a scale by patient at baseline and post-treatment. Higher scores mean a worse outcome.
Conditions Studied
Interventions
- DEVICE Sustained Acoustic Device with 2.5% Diclofenac Patch
- DRUG 2.5% Diclofenac Patches
- DEVICE Sustained Acoustic Device with 0% Diclofenac Patch
Study Locations (3)
Connecticut
- Orthopaedic Foundation - Stamford
- ZetrOZ Systems - Trumbull
New York
- Cayuga Medical Center - Medical Pain Consultants - Dryden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-06-03 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 2 |
What the finished NCT05882812 record still lists
NCT05882812 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 3 interventions - of which Sustained Acoustic Device with 2.5% Diclofenac Patch is the first listed.
NCT05882812 reports a single indexed study location in Connecticut, New York.
Frequently Asked Questions
What is clinical trial NCT05882812 about?
NCT05882812 is a clinical study titled "Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis". The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over an 8-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthriti...
What is the current status of trial NCT05882812?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2023-06-03. Estimated completion is 2024-02-22.
What conditions does trial NCT05882812 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Arthritis.
What interventions are being tested in trial NCT05882812?
The interventions under investigation include: Sustained Acoustic Device with 2.5% Diclofenac Patch (DEVICE), 2.5% Diclofenac Patches (DRUG), Sustained Acoustic Device with 0% Diclofenac Patch (DEVICE).
Who is sponsoring clinical trial NCT05882812?
This trial is sponsored by ZetrOZ, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05882812 being conducted?
This trial has 3 study locations across Connecticut, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05882812's enrollment target sits among peer trials
200 32nd of 112 higher than 78 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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