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NCT01541748 · ClinicalTrials.gov registry record
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
A clinical trial of Pelvic Organ Prolapse, sponsored by Coloplast A/S.
- Completed
- Registry status
- 74
- Enrollment target
- 5
- Study locations
NCT01541748: Completed study of Pelvic Organ Prolapse, sponsored by Coloplast A/S.
NCT01541748 is a study of Pelvic Organ Prolapse that has completed, run by Coloplast A/S. The registered enrollment target is 74 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (48% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01541748, a study of Pelvic Organ Prolapse, has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- 74 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
Primary Outcome
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are: Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1
Conditions Studied
Interventions
- OTHER Axis
Study Locations (5)
Pennsylvania
- The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown
- Philadelphia Urosurgical Associates - Philadelphia
Florida
- Cleveland Clinic Florida - Weston
Massachusetts
- Boston Urogynecology Associates - Cambridge
Michigan
- Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2011-11 |
| Est. Completion | 2018-11-11 |
What the finished NCT01541748 record still lists
NCT01541748 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 1 intervention - of which Axis is the first listed.
NCT01541748 lists 5 locations in 4 states (Pennsylvania, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT01541748 about?
NCT01541748 is a clinical study titled "Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study". This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
What is the current status of trial NCT01541748?
This trial is currently completed. The enrollment target is 74 participants. The study started on 2011-11. Estimated completion is 2018-11-11.
What conditions does trial NCT01541748 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT01541748?
The interventions under investigation include: Axis (OTHER).
Who is sponsoring clinical trial NCT01541748?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01541748 being conducted?
This trial has 5 study locations across Florida, Massachusetts, Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01541748's enrollment target sits among peer trials
74 28th of 40 higher than 13 of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
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