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Post-Market Clinical Follow-Up onTVT EXACT® Continence System
NCT04829994 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Conditions Studied
Interventions
- DEVICE Intervention
Study Locations (8)
Other
- Ordensklinikum Linz — Linz
- Herlev Hospital — Hillerød
- Hopital Jeanne de Flandres — Lille
- Universitatsklinikum Tubingen — Tübingen
- Karolinska Institute — Stockholm
Pennsylvania
- Institute for Female Pelvic Medicine — North Wales
- UPMC — Pittsburgh
North Carolina
- Duke University — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2021-07-07 |
| Est. Completion | 2035-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04829994
The ClinicalTrials.gov registry entry for NCT04829994 describes a study currently listed as active not 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 198 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: NCT04829994 reports 8 study locations spanning 3 distinct geographic areas — top geographies include Other, Pennsylvania, North Carolina. 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 NCT04829994 about?
NCT04829994 is a clinical study titled "Post-Market Clinical Follow-Up onTVT EXACT® Continence System". The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
What is the current status of trial NCT04829994?
This trial is currently active not recruiting. The enrollment target is 198 participants. The study started on 2021-07-07. Estimated completion is 2035-09-30.
What conditions does trial NCT04829994 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 NCT04829994?
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 NCT04829994?
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 NCT04829994 being conducted?
This trial has 8 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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