CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
Sustained Acoustic Device with 1% Diclofenac patchcombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04391842
NCT04391842Phase 1Completed
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Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis

ZetrOZ, Inc.·interventional·Posted May 18, 2020·Updated Jun 27, 2023

In Brief

A Phase 1 clinical trial evaluating Sustained Acoustic Device with 1% Diclofenac patch for Osteo Arthritis Knee and Arthritis. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II and stage III knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase function of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteo Arthritis Knee, Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 18, 2020
Enrollment StartSep 1, 2019
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.1 years ago

Interventions

Sustained Acoustic Device with 1% Diclofenac patchcombination

Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device