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 December 2012 by American Medical Systems
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT01673360
First received: August 23, 2012
Last updated: December 18, 2012
Last verified: December 2012
  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 2019
Estimated Primary Completion Date: September 2014 (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 Not yet 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, 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         
Belgium
BVBA Dr. Dieter Ost Not yet recruiting
Dendermonde, Belgium
UZ Gent Not yet recruiting
Gent, Belgium
Canada, Ontario
Windsor Research Office Not yet 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 Not yet 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 Recruiting
Berlin, Germany, 11 10115
Contact: Ralf Tunn, MD    +49-30-23112106    r.tunn@alexius.de   
Principal Investigator: Prof Ralf Tunn, MD         
Waldburg-Zeil Kliniken Klinik Tettnang Recruiting
Tettnang, Germany, 16 88069
Contact: Christian Fünfgeld, MD    0049 7542 531 301    christian.fuenfgeld@t-online.de   
Principal Investigator: Christian Fünfgeld, MD         
Slovenia
University Medical Centre Maribor Not yet recruiting
Maribor, Slovenia
South Africa
Pretoria Urology Hospital Not yet recruiting
Pretoria, South Africa
Spain
Hospital Clínico y Provincial de Barcelona Not yet recruiting
Barcelona, Spain
Contact: Eduardo Bataller, MD    34932275534    ebatalle@clinic.ub.es   
Principal Investigator: Eduardo Bataller, MD         
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 Recruiting
Valladolid, Spain
Contact: Jose Maria Martinez-Sagarra, MD PhD    +0034 983 420400    jmmso@hotmail.com   
Principal Investigator: Carlos Marina, MD         
Principal Investigator: Jose Maria Martinez-Sagarra, MD         
United Kingdom
Royal Bolton Hospital Recruiting
Bolton, United Kingdom
Contact: Philip Chia, MD    00441204390954    Phil.chia@rbh.nhs.uk   
Principal Investigator: Philip Chia, MD         
Glasgow - Southern General Hospital Recruiting
Glasgow, United Kingdom
Contact: Karen Guerrero, MD    +44 141 2012237    Karen.guerrero@ggc.scot.nhs.uk   
Principal Investigator: Hassan Ali, MD         
Principal Investigator: Karen Guerrero, MD         
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: December 18, 2012
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

Keywords provided by American Medical Systems:
vaginal repair
urinary slings
POP
SUI
prolapse
incontinence

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

ClinicalTrials.gov processed this record on July 20, 2014