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Feasibility Study of A VoRo UrologIc ScaffolD (ARID)
Sponsor: Levee Medical, Inc.
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.
Official title: Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary Incontinence
Key Details
Gender
MALE
Age Range
45 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-04-03
Completion Date
2026-10-30
Last Updated
2025-03-06
Healthy Volunteers
No
Interventions
Voro Urologic Scaffold
radical prostatectomy
Locations (1)
National Hospital
Panama City, Punta Pacifica, Panama