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NCT06217328 · ClinicalTrials.gov registry record · NA
RESTORE: An RCT to Evaluate the Efficacy of the Revi System
A NA study of Urinary Urge Incontinence, sponsored by BlueWind Medical.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 19
- Study locations
NCT06217328: Active NA study of Urinary Urge Incontinence, sponsored by BlueWind Medical.
NCT06217328 is a NA study of Urinary Urge Incontinence that is active but no longer recruiting, run by BlueWind Medical. The registered enrollment target is 150 participants, above the 77-participant average among 6 other Urinary Urge Incontinence trials with a reported enrollment target (95% higher). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06217328, a NA study of Urinary Urge Incontinence, is active but no longer recruiting, sponsored by BlueWind Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 19
- Study locations
Study Summary
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
Primary Outcome
Superiority of active Revi therapy over non-active therapy in the treatment of subjects with urinary urge incontinence based on a 3-day voiding diary
Conditions Studied
Interventions
- DEVICE Revi System Treatment
- DEVICE Revi System - Delayed Activation
Study Locations (19)
Texas
- Urology Partners of North Texas - Arlington
- University of Texas Southwestern - Department of Urology - Dallas
- DHR Health Institute for Research and Development - Edinburg
- The Urology Place - San Antonio
California
- Pasadena Urology - Pasadena
- Riverside Medical Clinic - Riverside
Illinois
- University of Chicago - Chicago
- Duly Health - Lombard
Arizona
- Arizona Urology Specialists - Tucson
Florida
- Florida Urology Partners - Tampa
Louisiana
- Willis-Knighton Clinical Research - Shreveport
Maryland
- Chesapeake Urology - Owings Mills
Missouri
- Specialty Clinical Research of St. Louis, LLC - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-02-24 |
| Est. Completion | 2027-02-28 |
| Phase | NA |
What the registry record for NCT06217328 still lists
NCT06217328 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 6 other Urinary Urge Incontinence trials with a reported enrollment target (95% higher).
The record links to 1 condition, with Urinary Urge Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Revi System Treatment is the first listed.
NCT06217328 lists 19 locations in 14 states (Texas, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT06217328 about?
NCT06217328 is a clinical study titled "RESTORE: An RCT to Evaluate the Efficacy of the Revi System". The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
What is the current status of trial NCT06217328?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-02-24. Estimated completion is 2027-02-28.
What conditions does trial NCT06217328 study?
This clinical trial studies the following conditions: Urinary Urge Incontinence.
What interventions are being tested in trial NCT06217328?
The interventions under investigation include: Revi System Treatment (DEVICE), Revi System - Delayed Activation (DEVICE).
Who is sponsoring clinical trial NCT06217328?
This trial is sponsored by BlueWind Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06217328 being conducted?
This trial has 19 study locations across Arizona, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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