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NCT04506177 · ClinicalTrials.gov registry record
Permanent Versus Delayed-Absorbable Monofilament Suture
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 200
- Enrollment target
NCT04506177: Completed study, sponsored by Wake Forest University Health Sciences.
NCT04506177 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04506177 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study Summary
This is an extension study of a prospective, multicenter, randomized, single-blind trial whose purpose is to compare mesh-related complications and effectiveness of pelvic organ prolapse (POP) repair in women undergoing minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment through at least 3 years after surgery.
Primary Outcome
Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 2 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify \<10% patient population during examination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2023-04-05 |
What the finished NCT04506177 record still lists
NCT04506177 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04506177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04506177 about?
NCT04506177 is a clinical study titled "Permanent Versus Delayed-Absorbable Monofilament Suture". This is an extension study of a prospective, multicenter, randomized, single-blind trial whose purpose is to compare mesh-related complications and effectiveness of pelvic organ prolapse (POP) repair in women undergoing minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weig...
What is the current status of trial NCT04506177?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2020-07-01. Estimated completion is 2023-04-05.
Who is sponsoring clinical trial NCT04506177?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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