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RECRUITING
NCT06873581
PHASE3

Pivotal Study of Voro Urologic Scaffold

Sponsor: Levee Medical, Inc.

View on ClinicalTrials.gov

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.

Official title: A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)

Key Details

Gender

MALE

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2025-04-18

Completion Date

2028-02-01

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DEVICE

Voro Urologic Scaffold

The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.

Locations (20)

Mayo Clinic

Phoenix, Arizona, United States

Academic Urology

Sun City, Arizona, United States

UCLA Urology

Los Angeles, California, United States

University of California San Diego

San Diego, California, United States

Tampa General Hospital

Tampa, Florida, United States

University of Chicago Medicine

Chicago, Illinois, United States

IU school of Medicine, Department of Urology

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

John Hopkins

Baltimore, Maryland, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

BMHCC/ Mississippi Urology Clinic

Jackson, Mississippi, United States

Northwell Health

New Hyde Park, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Erlanger Urology

Chattanooga, Tennessee, United States

The Conrad Pearson Clinic

Germantown, Tennessee, United States

Urology Associates PC Nashville

Nashville, Tennessee, United States

Urology of Austin

Austin, Texas, United States

Potomac Urology Center

Alexandria, Virginia, United States

Urology of Virginia, PLLC

Virginia Beach, Virginia, United States