MedTrace Logo

Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products

NCT00388947 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1543

Last updated 2016-08-11

Study results available
· View outcomes & findings →

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.

Conditions

  • Vaginal Prolapse

Interventions

DEVICE

AMS Prolapse Product

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

Sponsors & Collaborators

  • ASTORA Women's Health

    lead INDUSTRY

Principal Investigators

  • Samuel Zylstra, MD · Whitinsville Medical Center

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00388947 on ClinicalTrials.gov