Clinical Trial

Pivotal Study of Voro Urologic Scaffold

Study acronym: ARID II
Active, Not Recruiting Phase 3
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.
Protocol Amendment History 3 changes
critical Enrollment closed, study ongoing 2026-08-01
notable Primary completion pushed: 2027-02-01 -> 2028-04-30 2026-05-02
minor Completion pushed: 2028-02-01 -> 2028-04-30 2026-05-02
Trial Details
NCT Number NCT06873581
Lead Sponsor Levee Medical, Inc.
Conditions Radical Prostatectomy, Stress Urinary Incontinence (SUI)
Enrollment 266 participants
Start Date 2025-04-18
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-31