CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 725 enrolled
Drug / intervention
AMS Apogee™ with IntePro +8 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00638235
NCT00638235N/ACompleted
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A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair

ASTORA Women's Health·observational·Posted Mar 19, 2008·Updated Oct 28, 2016

In Brief

An observational study evaluating AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, and 7 other interventions for Pelvic Organ Prolapse. Completed, enrolled 725 participants across 28 sites in 7 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPelvic Organ Prolapse
CountriesBelgium, France, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2008
Enrollment StartMay 1, 2006
Primary CompletionFeb 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.3 years ago

Interventions

AMS Apogee™ with InteProdevice

Mesh implant for posterior wall pelvic organ prolapse

AMS Apogee™ with Intexen LPdevice

Graft implant for posterior wall pelvic organ prolapse

AMS Perigee™ with InteProdevice

Mesh implant for anterior wall pelvic organ prolapse

AMS Perigee™ with IntePro Litedevice

Mesh implant for anterior wall pelvic organ prolapse

AMS Apogee™ with IntePro Litedevice

Mesh implant for posterior wall pelvic organ prolapse

AMS Elevate™ Apical & Posteiror with IntePro Litedevice

Mesh implant for apical and posterior wall pelvic organ prolapse

AMS Elevate™ Apical & Posteiror with IntXen LPdevice

Graft implant for apical and posterior wall pelvic organ prolapse

AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)device

Mesh implant for anteiror and apical wall pelvic organ prolapse

AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)device

Mesh implant for anteiror and apical wall pelvic organ prolapse