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NCT01945580 · ClinicalTrials.gov registry record · NA
Xenform Postmarket Surveillance Study
A NA study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 374
- Enrollment target
NCT01945580: Completed NA study, sponsored by Boston Scientific Corporation.
NCT01945580 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 374 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01945580, a NA study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 374 participants
- Enrollment target
Study Summary
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
Primary Outcome
The primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Xenform over NTR at 36 months as compared to baseline. Success was based on a composite of objective and subjective measures. 1. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). 2. Anatomic success (in the operated compartment): * Anterior segment: Le
Interventions
- PROCEDURE Prolapse Repair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2014-02-10 |
| Est. Completion | 2020-02-12 |
| Phase | NA |
What the finished NCT01945580 record still lists
NCT01945580 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Prolapse Repair is the first listed.
NCT01945580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01945580 about?
NCT01945580 is a clinical study titled "Xenform Postmarket Surveillance Study". To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
What is the current status of trial NCT01945580?
This trial is currently completed. It is a NA study. The enrollment target is 374 participants. The study started on 2014-02-10. Estimated completion is 2020-02-12.
What interventions are being tested in trial NCT01945580?
The interventions under investigation include: Prolapse Repair (PROCEDURE).
Who is sponsoring clinical trial NCT01945580?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01945580's enrollment target sits among peer trials
374 280th of 2000 higher than 1,721 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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