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Pivotal Study of Voro Urologic Scaffold
Sponsor: Levee Medical, Inc.
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
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