Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006438

Trial Description

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Title

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

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Trial Acronym

CAPTURE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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

- Efficacy

- Safety

- Patient reported outcomes

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00006438
  •   2015/01/09
  •   2012/08/23
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01673360  (ClinicalTrials.gov)
  •   PR1102  (American Medical Systems)
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Health Condition or Problem studied

  •   Female Stress Incontinence
  •   Pelvic Organ Prolapse
  •   N39.3 -  Stress incontinence
  •   N81 -  Female genital prolapse
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Interventions/Observational Groups

  •   Device: Prolapse (AMS prolapse products)
  •   Device: Urinary Incontinence (Mini Arc Pro)
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Prolapse Efficacy - POP-Q; time frame: annually, upto 5 years; Prolapse Endpoints:
• POP-Q measurement
- Urinary Incontinence Endpoints; time frame: annually upto 5 years; Urinary Incontinence Endpoints:
Cough stress test
1 hour pad weight test
Urodynamics

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   United States
  •   Canada
  •   France
  •   Germany
  •   Slovenia
  •   South Africa
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2012/09/30
  •   5000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • American Medical Systems
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    •   [---]*
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    • CAPTURE TEAM 
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    • CAPTURE TEAM 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.