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NCT06873581 · ClinicalTrials.gov registry record · Phase 3
Pivotal Study of Voro Urologic Scaffold
A Phase 3 study of Radical Prostatectomy and Stress Urinary Incontinence (SUI), sponsored by Levee Medical.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 266
- Enrollment target
- 20
- Study locations
NCT06873581: Recruiting Phase 3 study of Radical Prostatectomy and Stress Urinary Incontinence (SUI), sponsored by Levee Medical.
NCT06873581 is a Phase 3 study of Radical Prostatectomy and Stress Urinary Incontinence (SUI) that is actively recruiting participants, run by Levee Medical. The registered enrollment target is 266 participants, above the 63-participant average among 3 other Radical Prostatectomy trials with a reported enrollment target (322% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06873581, a Phase 3 study of Radical Prostatectomy and Stress Urinary Incontinence (SUI), is actively recruiting participants, sponsored by Levee Medical.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 266 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
Primary Outcome
AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants during the course of the study, whether or not related to the investigational device.
Conditions Studied
Interventions
- DEVICE Voro Urologic Scaffold
Study Locations (20)
New York
- Northwell Health - New Hyde Park
- Memorial Sloan Kettering Cancer Center - New York
- University of Rochester Medical Center - Rochester
Tennessee
- Erlanger Urology - Chattanooga
- The Conrad Pearson Clinic - Germantown
- Urology Associates PC Nashville - Nashville
Arizona
- Mayo Clinic - Phoenix
- Academic Urology - Sun City
California
- UCLA Urology - Los Angeles
- University of California San Diego - San Diego
Maryland
- University of Maryland - Baltimore
- John Hopkins - Baltimore
Virginia
- Potomac Urology Center - Alexandria
- Urology of Virginia, PLLC - Virginia Beach
Florida
- Tampa General Hospital - Tampa
Illinois
- University of Chicago Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2025-04-18 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 3 |
What NCT06873581 shows while recruiting
NCT06873581 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 3 other Radical Prostatectomy trials with a reported enrollment target (322% higher).
The record links to 2 conditions, with Radical Prostatectomy appearing as the primary indexed condition, and to 1 intervention - of which Voro Urologic Scaffold is the first listed.
NCT06873581 names 20 study sites across 12 states, led by New York, Tennessee, Arizona.
Frequently Asked Questions
What is clinical trial NCT06873581 about?
NCT06873581 is a clinical study titled "Pivotal Study of Voro Urologic Scaffold". The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated...
What is the current status of trial NCT06873581?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 266 participants. The study started on 2025-04-18. Estimated completion is 2028-02-01.
What conditions does trial NCT06873581 study?
This clinical trial studies the following conditions: Radical Prostatectomy, Stress Urinary Incontinence (SUI).
What interventions are being tested in trial NCT06873581?
The interventions under investigation include: Voro Urologic Scaffold (DEVICE).
Who is sponsoring clinical trial NCT06873581?
This trial is sponsored by Levee Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06873581 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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