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NCT02162628 · ClinicalTrials.gov registry record
Exair® Versus Native Tissue Repair for Prolapse
A clinical trial, sponsored by Coloplast A/S.
- Terminated
- Registry status
- 79
- Enrollment target
NCT02162628: Clinical Trial study, sponsored by Coloplast A/S.
NCT02162628 is a clinical trial that was terminated before completion, run by Coloplast A/S. The registered enrollment target is 79 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02162628 was terminated before completion, sponsored by Coloplast A/S.
- TERMINATED
- Registry status
- 79 participants
- Enrollment target
Study Summary
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
Primary Outcome
Recurrent prolapse is measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Interventions
- DEVICE Exair Prolapse Repair System
- PROCEDURE Total Native Tissue Repair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-12 |
Why NCT02162628 stopped before completion
NCT02162628 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 79 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Exair Prolapse Repair System is the first listed.
NCT02162628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02162628 about?
NCT02162628 is a clinical study titled "Exair® Versus Native Tissue Repair for Prolapse". The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
What is the current status of trial NCT02162628?
This trial is currently terminated. The enrollment target is 79 participants. The study started on 2014-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02162628?
The interventions under investigation include: Exair Prolapse Repair System (DEVICE), Total Native Tissue Repair (PROCEDURE).
Who is sponsoring clinical trial NCT02162628?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
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