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RECRUITING

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

NCT04829357 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

Interventions

  • DEVICE Intervention

Study Locations (4)

Other

  • Bio-Medical University Rome — Rome
  • Ospedale San Pietro Fatebenefratelli — Rome
  • Ospedale Regionale Beata Vergine — Mendrisio

Pennsylvania

  • Institute for Female Pelvic Medicine — North Wales

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2021-09-09
Est. Completion 2038-12-31

Sponsor

Ethicon

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04829357

The ClinicalTrials.gov registry entry for NCT04829357 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ethicon, which has 37 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 Intervention 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: NCT04829357 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Other, Pennsylvania. 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 NCT04829357 about?

NCT04829357 is a clinical study titled "Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System". The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

What is the current status of trial NCT04829357?

This trial is currently recruiting. The enrollment target is 195 participants. The study started on 2021-09-09. Estimated completion is 2038-12-31.

What conditions does trial NCT04829357 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 NCT04829357?

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

Who is sponsoring clinical trial NCT04829357?

This trial is sponsored by Ethicon, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04829357 being conducted?

This trial has 4 study locations across Pennsylvania. 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