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Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

NCT06275945 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence
  • Radical Prostatectomy

Interventions

DEVICE

Voro Urologic Scaffold

radical prostatectomy

Sponsors & Collaborators

  • RQM+

    collaborator INDUSTRY

  • Levee Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Choi · Founder and CTO, Levee Medical, Inc

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2026-07-30
Completion
2026-10-30

Countries

  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275945 on ClinicalTrials.gov