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NCT00638235 · ClinicalTrials.gov registry record
Pelvic Floor Repair Systems for Prolapse Repair
A clinical trial, sponsored by ASTORA Women's Health.
- Completed
- Registry status
- 725
- Enrollment target
NCT00638235: Completed study, sponsored by ASTORA Women's Health.
NCT00638235 is a clinical trial that has completed, run by ASTORA Women's Health. The registered enrollment target is 725 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00638235 has completed, sponsored by ASTORA Women's Health.
- COMPLETED
- Registry status
- 725 participants
- Enrollment target
Study Summary
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair. 3. The study population is female subjects \> 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse. 4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure. 5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.
Primary Outcome
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed th
Interventions
- DEVICE AMS Apogee™ with IntePro
- DEVICE AMS Apogee™ with Intexen LP
- DEVICE AMS Perigee™ with IntePro
- DEVICE AMS Perigee™ with IntePro Lite
- DEVICE AMS Apogee™ with IntePro Lite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 725 participants |
| Start Date | 2006-05 |
| Est. Completion | 2012-09 |
What the finished NCT00638235 record still lists
NCT00638235 is an observational study that tracks outcomes without assigning an intervention. The registered 725 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which AMS Apogee™ with IntePro is the first listed.
NCT00638235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00638235 about?
NCT00638235 is a clinical study titled "Pelvic Floor Repair Systems for Prolapse Repair". 1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair. 3. The study population is female subjects \> 21 year...
What is the current status of trial NCT00638235?
This trial is currently completed. The enrollment target is 725 participants. The study started on 2006-05. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00638235?
The interventions under investigation include: AMS Apogee™ with IntePro (DEVICE), AMS Apogee™ with Intexen LP (DEVICE), AMS Perigee™ with IntePro (DEVICE), AMS Perigee™ with IntePro Lite (DEVICE), AMS Apogee™ with IntePro Lite (DEVICE).
Who is sponsoring clinical trial NCT00638235?
This trial is sponsored by ASTORA Women's Health, which has 7 total clinical trials registered on ClinicalTrials.gov.
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