CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,543 enrolled
Drug / intervention
AMS Prolapse Productdevice
Likely dose
Not stated in record
Key inclusion· 3
  • Female at least 21 years old
  • Has pelvic organ prolapse requiring surgical repair
  • Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse
Key exclusion· 1
  • Contraindicated for an AMS Prolapse Repair per the product's Instruction for Use

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

Search/NCT00388947
NCT00388947N/ACompleted

The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse

ASTORA Women's Health·observational·Posted Oct 17, 2006·Updated Aug 11, 2016

In Brief

An observational study evaluating AMS Prolapse Product for Vaginal Prolapse. Completed, enrolled 1,543 participants across 1 site.

Detailed Summary

This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2006
Enrollment StartSep 1, 2006
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 19.7 years ago

Interventions

AMS Prolapse Productdevice

AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family