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Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

NCT01673360 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 401

Last updated 2016-06-17

No results posted yet for this study

Summary

To monitor post-market performance through evaluation of short and long-term performance via:

* Efficacy
* Safety
* Patient reported outcomes

Conditions

  • Female Stress Incontinence
  • Pelvic Organ Prolapse

Interventions

DEVICE

Elevate PC

List of AMS prolapse products

DEVICE

Mini Arc Pro

List of AMS Urinary Incontinence devices

DEVICE

RetroArc

List of AMS Urinary Incontinence devices

Sponsors & Collaborators

  • ASTORA Women's Health

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Slovenia
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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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 NCT01673360 on ClinicalTrials.gov