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Active, not recruiting Phase 3 Interventional

Pivotal Study of Voro Urologic Scaffold

ClinicalTrials.gov ID: NCT06873581

Public ClinicalTrials.gov record NCT06873581. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 4:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06873581
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Levee Medical, Inc.
Industry
Enrollment
266 participants

Conditions and interventions

Eligibility (public fields only)

Age range
45 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 18, 2025 (Actual)
Primary completion
Apr 30, 2028 (Estimated)
Completion
Apr 30, 2028 (Estimated)
Last update posted
Sep 30, 2026

2025 – 2028

United States locations

U.S. sites
19
U.S. states
11
U.S. cities
18
Facility City State ZIP Site status
Mayo Clinic Phoenix Arizona 85054 —
Academic Urology Sun City Arizona 85351 —
University of California Los Angeles Los Angeles California 90095 —
University of California San Diego San Diego California 92093 —
Tampa General Hospital Tampa Florida 33606 —
University of Chicago Medicine Chicago Illinois 60611 —
IU school of Medicine, Department of Urology Indianapolis Indiana 46202 —
University of Maryland Baltimore Maryland 21201 —
John Hopkins Baltimore Maryland 21287 —
BMHCC/ Mississippi Urology Clinic Jackson Mississippi 39202 —
Northwell Health New Hyde Park New York 11042 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
University of Rochester Medical Center Rochester New York 14620 —
Erlanger Urology Chattanooga Tennessee 37403 —
The Conrad Pearson Clinic Germantown Tennessee 38138 —
Urology Associates PC Nashville Nashville Tennessee 37209 —
Urology of Austin Austin Texas 78759 —
Potomac Urology Center Alexandria Virginia 22311 —
Urology of Virginia, PLLC Virginia Beach Virginia 23462 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06873581, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 30, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06873581 live on ClinicalTrials.gov.

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