Clinical Trial

Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

Study acronym: ARID
Active, Not Recruiting Phase 2
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Record status
This record was last updated March 6, 2025 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence. The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-02-16.
Status change: Recruiting → Active, Not Recruiting 2025-03-03
Trial Details
NCT Number NCT06275945
Lead Sponsor Levee Medical, Inc.
Collaborators: RQM+
Conditions Stress Urinary Incontinence, Radical Prostatectomy
Enrollment 40 participants
Start Date 2023-04-03
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-06