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NCT06862648 · ClinicalTrials.gov registry record · NA
Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
A NA study of Stress Urinary Incontinence (SUI), sponsored by Acoustic Wave Cell Therapy.
- Recruiting
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 7
- Study locations
NCT06862648 is a NA study of Stress Urinary Incontinence (SUI) that is actively recruiting participants, run by Acoustic Wave Cell Therapy. The registered enrollment target is 130 participants. The trial reports 7 study locations across 7 states.
The verdict
NCT06862648, a NA study of Stress Urinary Incontinence (SUI), is actively recruiting participants, sponsored by Acoustic Wave Cell Therapy.
- RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 7
- Study locations
Study Summary
The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years. The main questions this study aims to answer are: 1. Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage. 2. Is the device safe and effective compared to the sham group? Participants will: 1. Be randomly assigned to an active or sham control group in a blinded, multicenter study. 2. Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals. 3. Enter a 3-month, treatment-free follow-up phase, with SUI assessment. 4. Proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit. The total study duration will last approximately 18 months, with each individual's participation lasting approximately 6-8 months. This study aims to provide robust data on the effectiveness, safety, and durability of the SUI-100 device for treating female Stress Urinary Incontinence.
Conditions Studied
Interventions
- DEVICE Acoustic Stimulation Therapy Device
- DEVICE Sham Acoustic Stimulation Therapy Device
Study Locations (7)
Arizona
- Arizona Gynecology Consultants - Phoenix
Florida
- Clinical Research of Central Florida - Winter Haven
Idaho
- Advanced Specialty Research - Boise
Kansas
- Cypress Medical Research Center - Wichita
Montana
- Boeson Research GTF - Great Falls
Nevada
- Foundation for Female Health Awareness - Las Vegas
Ohio
- Helios Clinical Research - Middleburg Heights
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-03-25 |
| Est. Completion | 2026-11-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06862648
The ClinicalTrials.gov registry entry for NCT06862648 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acoustic Wave Cell Therapy, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stress Urinary Incontinence (SUI) appearing as the primary indexed condition, and to 2 interventions - of which Acoustic Stimulation Therapy Device is the first listed.
NCT06862648 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Arizona, Florida, Idaho.
Frequently Asked Questions
What is clinical trial NCT06862648 about?
NCT06862648 is a clinical study titled "Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence". The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years. The main questions this study aims to answer are: 1. Does treatment with the SUI-100 device...
What is the current status of trial NCT06862648?
This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2025-03-25. Estimated completion is 2026-11-09.
What conditions does trial NCT06862648 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence (SUI).
What interventions are being tested in trial NCT06862648?
The interventions under investigation include: Acoustic Stimulation Therapy Device (DEVICE), Sham Acoustic Stimulation Therapy Device (DEVICE).
Who is sponsoring clinical trial NCT06862648?
This trial is sponsored by Acoustic Wave Cell Therapy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06862648 being conducted?
This trial has 7 study locations across Arizona, Florida, Idaho, Kansas, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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