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

Sponsor
ASTORA Women's Health (Industry)
Overall Status
Terminated
CT.gov ID
NCT01673360
Collaborator
(none)
401
19
111
21.1
0.2

Study Details

Study Description

Brief Summary

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

  • Safety

  • Patient reported outcomes

Condition or Disease Intervention/Treatment Phase
  • Device: Elevate PC
  • Device: Mini Arc Pro
  • Device: RetroArc

Detailed Description

As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:

  • Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires

  • Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product

  • Collect concomitant procedural data related to the pelvic floor area

Study Design

Study Type:
Observational
Actual Enrollment :
401 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Study Start Date :
Sep 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Elevate PC

Subjects implanted with Elevate PC

Device: Elevate PC
List of AMS prolapse products

Mini Arc Pro

Subjects implanted with Mini Arc Pro

Device: Mini Arc Pro
List of AMS Urinary Incontinence devices

RetroArc

Subjects implanted with RetroArc

Device: RetroArc
List of AMS Urinary Incontinence devices

Outcome Measures

Primary Outcome Measures

  1. Prolapse Efficacy - POP-Q [annually, upto 5 years]

    Prolapse Endpoints: • POP-Q measurement

  2. Urinary Incontinence Endpoints [annually upto 5 years]

    Urinary Incontinence Endpoints: Cough stress test 1 hour pad weight test Urodynamics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients must meet all of the following criteria to be considered for inclusion in the registry.

  • Have a signed Informed Consent Form

  • Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US

  • Is a female at least 18 years of age

  • Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.

  • Is able and willing to participate in the registry

Exclusion Criteria:
  • Patients will be excluded from the registry if any one of the following criteria is met.

  • Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atlanta Medical Research Institute Alpharetta Georgia United States 30005
2 Morristown Memorial Hospital Morristown New Jersey United States 07962
3 Womancare Winston-Salem North Carolina United States 27103
4 Seven Hills Women's Health Centers Cinncinatti Ohio United States 45242
5 The Female Pelvic Health Center Newtown Pennsylvania United States 18940
6 Female Pelvic Medicine Institute of Virginia Richmond Virginia United States 23235
7 The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre Ottawa Ontario Canada K1H 7W9
8 Windsor Research Office Windsor Ontario Canada N8W 5L7
9 CMC Beau Soleil Montpellier France 34070
10 Hôpital BICÊTRE Paris France
11 German Pelvic Floor Center, St. Hedwig Hospital Berlin Germany 11 10115
12 Waldburg-Zeil Kliniken Klinik Tettnang Tettnang Germany 16 88069
13 University Medical Centre Maribor Maribor Slovenia
14 Pretoria Urology Hospital Pretoria South Africa
15 Hospital Clínico y Provincial de Barcelona Barcelona Spain
16 Hospital Beata María Ana de Jesus Madrid Spain
17 Hospital Rio Hortega Valladolid Spain
18 Royal Bolton Hospital Bolton United Kingdom
19 Glasgow - Southern General Hospital Glasgow United Kingdom

Sponsors and Collaborators

  • ASTORA Women's Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ASTORA Women's Health
ClinicalTrials.gov Identifier:
NCT01673360
Other Study ID Numbers:
  • PR1102
First Posted:
Aug 28, 2012
Last Update Posted:
Jun 17, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by ASTORA Women's Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 17, 2016