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Pivotal Study of Voro Urologic Scaffold

NCT06873581 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

  • Radical Prostatectomy
  • Stress Urinary Incontinence (SUI)

Interventions

DEVICE

Voro Urologic Scaffold

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

Sponsors & Collaborators

  • Levee Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Karen Cornett · Vice President, Levee Medical, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873581 on ClinicalTrials.gov