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RECRUITING NA

ProACT Post-Approval Study

NCT03767595 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DEVICE ProACT Adjustable Continence Therapy for Men

Study Locations (6)

Colorado

  • University of Colorado — Denver

Florida

  • University of Florida — Gainesville

Georgia

  • Emory University — Atlanta

Kansas

  • University of Kansas Medical Center — Kansas City

Michigan

  • University of Michigan — Ann Arbor

Minnesota

  • CentraCare- St. Cloud — Saint Cloud

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2019-02-19
Est. Completion 2030-09-01
Phase NA

Sponsor

Uromedica

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03767595

The ClinicalTrials.gov registry entry for NCT03767595 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uromedica, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention — of which ProACT Adjustable Continence Therapy for Men is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03767595 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Colorado, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03767595 about?

NCT03767595 is a clinical study titled "ProACT Post-Approval Study". 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 s...

What is the current status of trial NCT03767595?

This trial is currently recruiting. It is a NA study. The enrollment target is 145 participants. The study started on 2019-02-19. Estimated completion is 2030-09-01.

What conditions does trial NCT03767595 study?

This clinical trial studies the following conditions: Stress Urinary Incontinence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03767595?

The interventions under investigation include: ProACT Adjustable Continence Therapy for Men (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03767595?

This trial is sponsored by Uromedica, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03767595 being conducted?

This trial has 6 study locations across Colorado, Florida, Georgia, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial