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NCT04480671 · ClinicalTrials.gov registry record · NA
Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy
A NA study of Pelvic Organ Prolapse, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT04480671 is a NA study of Pelvic Organ Prolapse that has completed, run by University of Pittsburgh. The registered enrollment target is 94 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04480671, a NA study of Pelvic Organ Prolapse, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus. An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.
Conditions Studied
Interventions
- PROCEDURE Level III support procedure
- PROCEDURE Minimally Invasive Sacrocolpopexy
- OTHER Transperineal ultrasound of the Pelvic Floor
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2020-08-26 |
| Est. Completion | 2024-07-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04480671
The ClinicalTrials.gov registry entry for NCT04480671 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (34% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 3 interventions - of which Level III support procedure is the first listed.
NCT04480671 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04480671 about?
NCT04480671 is a clinical study titled "Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy". This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome ...
What is the current status of trial NCT04480671?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2020-08-26. Estimated completion is 2024-07-25.
What conditions does trial NCT04480671 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT04480671?
The interventions under investigation include: Level III support procedure (PROCEDURE), Minimally Invasive Sacrocolpopexy (PROCEDURE), Transperineal ultrasound of the Pelvic Floor (OTHER).
Who is sponsoring clinical trial NCT04480671?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04480671 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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