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RECRUITING

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

NCT04829058 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.

Conditions Studied

Interventions

  • DEVICE Intervention

Study Locations (3)

Pennsylvania

  • Institute for Female Pelvic Medicine — North Wales
  • UMPC — Pittsburgh

Other

  • Universitatsklinikum Tubingen — Tübingen

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2021-11-24
Est. Completion 2032-03-31

Sponsor

Ethicon

37 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04829058

The ClinicalTrials.gov registry entry for NCT04829058 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 100 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 Pelvic Organ Prolapse 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: NCT04829058 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, Other. 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 NCT04829058 about?

NCT04829058 is a clinical study titled "GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study". The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.

What is the current status of trial NCT04829058?

This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2021-11-24. Estimated completion is 2032-03-31.

What conditions does trial NCT04829058 study?

This clinical trial studies the following conditions: Pelvic Organ Prolapse. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04829058?

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 NCT04829058?

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 NCT04829058 being conducted?

This trial has 3 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