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ACTIVE NOT RECRUITING
NCT06275945
PHASE2

Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

Sponsor: Levee Medical, Inc.

View on ClinicalTrials.gov

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

DEVICE

Voro Urologic Scaffold

radical prostatectomy

Locations (1)

National Hospital

Panama City, Punta Pacifica, Panama