Pelvic Floor Repair Systems for Prolapse Repair
Public ClinicalTrials.gov record NCT00638235. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00638235
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 725 participants
Conditions and interventions
Conditions
Interventions
- 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
- AMS Elevate™ Apical & Posteiror with IntePro Lite Device
- AMS Elevate™ Apical & Posteiror with IntXen LP Device
- AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only) Device
- AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2) Device
Device
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2006 (Type not available)
- Primary completion
- Feb 2011 (Actual)
- Completion
- Sep 2012 (Actual)
- Last update posted
- Oct 28, 2016
2006 – 2012
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente - Dept. of Obstetrics & Gynecology | Downey | California | 90242 | — |
| Institute for Women's Health & Body | Wellington | Florida | 33414 | — |
| Atlanta Medical Research Institute | Alpharetta | Georgia | 30005 | — |
| Rosemark Womencare Specialists | Idaho Falls | Idaho | 83404 | — |
| Fore River Urology | Portland | Maine | 04102 | — |
| Maine Medical Partners | Portland | Maine | 04102 | — |
| Female Pelvic Health | Whitinsville | Massachusetts | 01588 | — |
| Female Pelvic Medicine and Urogynecology Inst. of Michigan | Grand Rapids | Michigan | 49503 | — |
| Michigan Medical P.C. | Grand Rapids | Michigan | 49546 | — |
| Women's Health Care Specialists, PC | Paw Paw | Michigan | 49079 | — |
| Metro Urology | Plymouth | Minnesota | 55441 | — |
| Piedmont Urology Associates | Gastonia | North Carolina | 28054 | — |
| Huey & Weprin Obstetrics & Gynecology | Englewood | Ohio | 45322 | — |
| South Carolina OB/GYN | Columbia | South Carolina | 29201 | — |
| University of Tennessee - Dept of Obstetrics & Gynecology | Memphis | Tennessee | 38103 | — |
| Texas Tech University Health Science Center - OB/GYN Department | El Paso | Texas | 79905 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00638235, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00638235 live on ClinicalTrials.gov.