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

This study has been terminated.
(Sponsor is winding down business operations)
Sponsor:
Information provided by (Responsible Party):
ASTORA Women's Health
ClinicalTrials.gov Identifier:
NCT01673360
First received: August 23, 2012
Last updated: June 16, 2016
Last verified: June 2016
  Purpose

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

  • Efficacy
  • Safety
  • Patient reported outcomes

Condition Intervention
Female Stress Incontinence
Pelvic Organ Prolapse
Device: Elevate PC
Device: Mini Arc Pro
Device: RetroArc

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

Resource links provided by NLM:


Further study details as provided by ASTORA Women's Health:

Primary Outcome Measures:
  • Prolapse Efficacy - POP-Q [ Time Frame: annually, upto 5 years ] [ Designated as safety issue: No ]

    Prolapse Endpoints:

    • POP-Q measurement


  • Urinary Incontinence Endpoints [ Time Frame: annually upto 5 years ] [ Designated as safety issue: No ]

    Urinary Incontinence Endpoints:

    • Cough stress test
    • 1 hour pad weight test
    • Urodynamics


Enrollment: 401
Study Start Date: September 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients planned to receive at least one (1) target AMS market approved female pelvic health product will be considered for inclusion in the registry.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673360

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

Responsible Party: ASTORA Women's Health
ClinicalTrials.gov Identifier: NCT01673360     History of Changes
Other Study ID Numbers: PR1102 
Study First Received: August 23, 2012
Last Updated: June 16, 2016
Health Authority: United States: Institutional Review Board
Spain: Ethics Committee
United Kingdom: National Health Service
Slovenia: Ethics Committee
France: Conseil National de l'Ordre des Médecins
France: French Data Protection Authority
Belgium: Ethics Committee
South Africa: Human Research Ethics Committee
Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by ASTORA Women's Health:
vaginal repair
urinary slings
POP
SUI
prolapse
incontinence

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Urinary Incontinence, Stress
Pathological Conditions, Anatomical
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 27, 2016