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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by American Medical Systems
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT01673360
First received: August 23, 2012
Last updated: August 12, 2014
Last verified: August 2014
  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: Prolapse (AMS prolapse products)
Device: Urinary Incontinence (Mini Arc Pro)

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 American Medical Systems:

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


Estimated Enrollment: 5000
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
Proplase Products
Subjects implanted with Elevate PC
Device: Prolapse (AMS prolapse products)
List of AMS prolapse products
Other Name: Elevate PC
Urinary Incontinence Group
Subjects implanted with Mini Arc Pro
Device: Urinary Incontinence (Mini Arc Pro)
List of AMS Urinary Incontinence devices
Other Name: Mini Arc Pro

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
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

Contacts
Contact: CAPTURE TEAM 952-930-6000 capture@ammd.com

Locations
United States, Georgia
Atlanta Medical Research Institute Recruiting
Alpharetta, Georgia, United States, 30005
Contact: Robert D Moore, DO    770-475-1395    moorer33@hotmail.com   
Principal Investigator: Robert D Moore, DO         
United States, New Jersey
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Charbel Salamon, MD       charbel.salamon@atlantichealth.org   
Principal Investigator: Charbel Salamon, MD         
United States, North Carolina
Womancare Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Douglas Miyazaki, MD    336-765-5470    Dmiyazaki@w-swomancare.com   
Principal Investigator: Douglas Miyazaki, MD         
United States, Ohio
Seven Hills Women's Health Centers Recruiting
Cinncinatti, Ohio, United States, 45242
Contact: Michael Karram, MD FACOG    513-791-6268    mkarrammd@yahoo.com   
Principal Investigator: Michael Karram, MD FACOG         
United States, Pennsylvania
The Female Pelvic Health Center Recruiting
Newtown, Pennsylvania, United States, 18940
Contact: Stephanie Molden       smolden@fphcenter.com   
United States, Virginia
Female Pelvic Medicine Institute of Virginia Recruiting
Richmond, Virginia, United States, 23235
Contact: Nathan Guerette, MD    804-323-2533    nlguerette@mac.com   
Principal Investigator: Nathan Guerette, MD         
Canada, Ontario
The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre Recruiting
Ottawa, Ontario, Canada, K1H 7W9
Contact: Kevin Baker       kbaker@ottawahospital.on.ca   
Windsor Research Office Recruiting
Windsor, Ontario, Canada, N8W 5L7
Contact: Biljana Basic-Panic    519-252-9399    bbasicpanic@yahoo.ca   
Sub-Investigator: Brad Jasey, MD         
Principal Investigator: John E Tomc, MD         
France
CMC Beau Soleil Recruiting
Montpellier, France, 34070
Contact: Dr. Christophe Courtieu    33 (0)4 67 75 97 56    c.courtieu@languedoc-mutualite.fr   
Principal Investigator: Dr. Christophe Courtieu         
Hôpital BICÊTRE Not yet recruiting
Paris, France
Germany
German Pelvic Floor Center, St. Hedwig Hospital Active, not recruiting
Berlin, Germany, 11 10115
Waldburg-Zeil Kliniken Klinik Tettnang Active, not recruiting
Tettnang, Germany, 16 88069
Slovenia
University Medical Centre Maribor Recruiting
Maribor, Slovenia
Contact: Igor But, MD       Igor But <but.igor@gmail.com>   
South Africa
Pretoria Urology Hospital Recruiting
Pretoria, South Africa
Contact: Fran VanWijk       vanwijkfrans@yahoo.com   
Spain
Hospital Clínico y Provincial de Barcelona Active, not recruiting
Barcelona, Spain
Hospital Beata María Ana de Jesus Recruiting
Madrid, Spain
Contact: Gregorio Escribano, MD    +0034914097557    gescribano@telefonica.net   
Principal Investigator: Gregorio Escribano, MD         
Hospital Rio Hortega Active, not recruiting
Valladolid, Spain
United Kingdom
Royal Bolton Hospital Active, not recruiting
Bolton, United Kingdom
Glasgow - Southern General Hospital Active, not recruiting
Glasgow, United Kingdom
Sponsors and Collaborators
American Medical Systems
  More Information

No publications provided

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT01673360     History of Changes
Other Study ID Numbers: PR1102
Study First Received: August 23, 2012
Last Updated: August 12, 2014
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: Research Ethics Board

Keywords provided by American Medical Systems:
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 16, 2014