Pivotal Study of Voro Urologic Scaffold
A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)
Levee Medical, Inc.
266 participants
Apr 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
Locations(19)
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NCT06873581