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NCT05050448 · ClinicalTrials.gov registry record · Phase 1
Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain
A Phase 1 study of Knee Osteoarthritis, sponsored by ZetrOZ.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT05050448: Completed Phase 1 study of Knee Osteoarthritis, sponsored by ZetrOZ.
NCT05050448 is a Phase 1 study of Knee Osteoarthritis that has completed, run by ZetrOZ. The registered enrollment target is 60 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05050448, a Phase 1 study of Knee Osteoarthritis, has completed, sponsored by ZetrOZ.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.
Primary Outcome
Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.
Conditions Studied
Interventions
- DEVICE Sustained Acoustic Device with 2.5% Diclofenac Patch
- DRUG 1% Diclofenac Topical Gel
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 | 60 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
What the finished NCT05050448 record still lists
NCT05050448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Sustained Acoustic Device with 2.5% Diclofenac Patch is the first listed.
NCT05050448 reports a single indexed study location in Connecticut, New York.
Frequently Asked Questions
What is clinical trial NCT05050448 about?
NCT05050448 is a clinical study titled "Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain". The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) w...
What is the current status of trial NCT05050448?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-08-01. Estimated completion is 2022-12-31.
What conditions does trial NCT05050448 study?
This clinical trial studies the following conditions: Knee Osteoarthritis.
What interventions are being tested in trial NCT05050448?
The interventions under investigation include: Sustained Acoustic Device with 2.5% Diclofenac Patch (DEVICE), 1% Diclofenac Topical Gel (DRUG).
Who is sponsoring clinical trial NCT05050448?
This trial is sponsored by ZetrOZ, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05050448 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
Similar trials for Knee Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05050448's enrollment target sits among peer trials
60 62nd of 101 higher than 37 of 101 other Knee Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Knee Osteoarthritis 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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