MedTrace Logo

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

NCT06217328 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-17

No results posted yet for this study

Summary

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

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.

Sponsors & Collaborators

  • BlueWind Medical

    lead INDUSTRY

Principal Investigators

  • Lori Fein · BlueWind Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-24
Primary Completion
2026-02-28
Completion
2027-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06217328 on ClinicalTrials.gov