RESTORE: An RCT to Evaluate the Efficacy of the Revi System

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 24, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
Urinary Urge Incontinence
Interventions
DEVICE

Revi System Treatment

The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable

DEVICE

Revi System - Delayed Activation

The Revi System is an implantable neuromodulation device placed in the ankle region that is activated by a battery-operated rechargeable external wearable. The system will be implanted but it will not be turned on until 4 months post implant procedure.

Trial Locations (17)

10461

RECRUITING

Montefiore Medical Center, The Bronx

21117

RECRUITING

Chesapeake Urology, Owings Mills

33615

RECRUITING

Florida Urology Partners, Tampa

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

57105

RECRUITING

Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic, Sioux Falls

63141

RECRUITING

Specialty Clinical Research of St. Louis, LLC, St Louis

68114

RECRUITING

Adult and Pediatric Urology and Urogynecology, Omaha

71103

RECRUITING

Willis-Knighton Clinical Research, Shreveport

75390

RECRUITING

University of Texas Southwestern - Department of Urology, Dallas

76017

RECRUITING

Urology Partners of North Texas, Arlington

78240

RECRUITING

The Urology Place, San Antonio

78539

RECRUITING

DHR Health Institute for Research and Development, Edinburg

84112

RECRUITING

University of Utah, Salt Lake City

85741

RECRUITING

Arizona Urology Specialists, Tucson

91101

RECRUITING

Pasadena Urology, Pasadena

92506

RECRUITING

Riverside Medical Clinic, Riverside

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BlueWind Medical

INDUSTRY

NCT06217328 - RESTORE: An RCT to Evaluate the Efficacy of the Revi System | Biotech Hunter | Biotech Hunter