๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-03-03

Feasibility Study of A VoRo UrologIc ScaffolD (ARID) (NCT06275945)

Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary Incontinence

๐Ÿ”ต Active, Not Recruiting Phase2 โš™๏ธ Medical Device Protocol Sponsor: Levee Medical, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: National Hospital โ€” Panama City, Punta Pacifica

Age range: 45 Years to 70 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • National Hospital โ€” Panama City, Punta Pacifica

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—