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Recruiting Not applicable Interventional Accepts healthy volunteers

ProACT Post-Approval Study

ClinicalTrials.gov ID: NCT03767595

Public ClinicalTrials.gov record NCT03767595. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 4:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.

Study identification

NCT ID
NCT03767595
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Uromedica
Industry
Enrollment
145 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years and older
Sex
Male
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 19, 2019 (Actual)
Primary completion
Dec 31, 2031 (Estimated)
Completion
Dec 31, 2031 (Estimated)
Last update posted
Oct 6, 2026

2019 – 2031

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
University of Southern California Los Angeles California 90033 Recruiting
Sutter Health Santa Barbara California 93110 Recruiting
University of Colorado Denver Colorado 80045 Recruiting
University of Florida Gainesville Florida 32610 Recruiting
Urological Research Network Corp Hialeah Florida 33016 Recruiting
Emory University Atlanta Georgia 30322 Recruiting
University of Kansas Medical Center Kansas City Kansas 66103 Recruiting
University of Michigan Ann Arbor Michigan 48109 Recruiting
CentraCare- St. Cloud Saint Cloud Minnesota 56303 Recruiting
CHI Health Research Omaha Nebraska 68124 Recruiting
Lehigh Valley Health Network Allentown Pennsylvania 18103 Recruiting
Allegheny Health Network Pittsburgh Pennsylvania 15212 Recruiting
Urology Partners of North Texas Research Institute Arlington Texas 76017 Recruiting
DHR Health Institute for Research and Development McAllen Texas 78504 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03767595, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03767595 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →