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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 is a clinical trial that has completed, run by ASTORA Women's Health. The registered enrollment target is 725 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00638235
The ClinicalTrials.gov registry entry for NCT00638235 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 725 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ASTORA Women's Health, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which AMS Apogee™ with IntePro is the first listed.
NCT00638235 reports 0 study locations.
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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