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NCT04829058 · ClinicalTrials.gov registry record
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
A clinical trial of Pelvic Organ Prolapse, sponsored by Ethicon.
- Recruiting
- Registry status
- 100
- Enrollment target
- 3
- Study locations
NCT04829058: Recruiting study of Pelvic Organ Prolapse, sponsored by Ethicon.
NCT04829058 is a study of Pelvic Organ Prolapse that is actively recruiting participants, run by Ethicon. The registered enrollment target is 100 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (30% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04829058, a study of Pelvic Organ Prolapse, is actively recruiting participants, sponsored by Ethicon.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam.
Conditions Studied
Interventions
- DEVICE Intervention
Study Locations (3)
Pennsylvania
- Institute for Female Pelvic Medicine - North Wales
- UMPC - Pittsburgh
Other
- Universitatsklinikum Tubingen - Tübingen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-11-24 |
| Est. Completion | 2032-03-31 |
What NCT04829058 shows while recruiting
NCT04829058 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (30% lower).
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.
NCT04829058 reports a single indexed study location in Pennsylvania, Other.
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.
What interventions are being tested in trial NCT04829058?
The interventions under investigation include: Intervention (DEVICE).
Who is sponsoring clinical trial NCT04829058?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04829058's enrollment target sits among peer trials
100 22nd of 40 higher than 18 of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Organ Prolapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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