Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009581

Trial Description

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Title

A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair

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Trial Acronym

PROPEL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

1. This is a prospective, single arm, multi-center, post market study, which will be
conducted under a common protocol.

2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic
Floor Repair System devices for prolapse repair.

3. The study population is female subjects > 21 years of age who require surgical
reconstruction of their pelvic floor due to prolapse.

4. The clinical data will be analyzed by comparing post-treatment data with the baseline
data, with the subject acting as her own control.The follow-up is for two years after
the procedure.

5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary
endpoint of the study. The secondary endpoints include quality of life changes from
baseline and adverse event rates.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00009581
  •   2015/10/26
  •   2008/02/28
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00638235  (ClinicalTrials.gov)
  •   1004  (American Medical Systems)
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Health Condition or Problem studied

  •   Pelvic Organ Prolapse
  •   N81 -  Female genital prolapse
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Interventions/Observational Groups

  •   Device: AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic)
  •   Device: AMS Perigee™ with IntePro
  •   Device: AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite
  •   Device: AMS Elevate™ Apical & Posterior
  •   Device: AMS Elevate™ Apical & Anterior (original design)
  •   Device: AMS Elevate™ Apical & Anterior
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Percent of subjects with an ICS POP-Q Stage of </= Stage I; time frame: 12-months

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Secondary Outcome

- Quality of Life as measure by Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12); time frame: 6, 12, & 24 months
- Procedural time; time frame: Procedure
- Estimated blood loss; time frame: Procedure
- Percent of subjects experiencing major device related complications; time frame: Through 24 months
- Rate of graft extrusions; time frame: Through 24 months
- Rates of de novo or worsening urinary and/or anal incontinence; time frame: Through 24 months
- Percent of subjects with an ICS POP-Q Stage of </= Stage I; time frame: 6 and 24 months
- Wong-Baker Faces Pain Scale; time frame: 6 weeks and 3 months
- Patient Satisfaction Questionnaire; time frame: 6, 12, & 24 months
- Surgical revision rate; time frame: Through 24 months

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Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Netherlands
  •   Spain
  •   United Kingdom
  •   United States
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2006/05/31
  •   750
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   21   Years
  •   no maximum age
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Additional Inclusion Criteria

-Have been diagnosed with one or more clinically significant anterior, apical or posterior
genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical
repair

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Exclusion Criteria

- The Investigator determines the subject is not a candidate for surgical repair of her
genital prolapse.

- Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee,
Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.

- Subject has active or latent systemic infection or signs of tissue necrosis.

- Subject has restricted leg motion (inability to abduct or adduct leg positioning in
the lithotomy position) with or without a hip replacement/prosthesis.

- Subject is currently pregnant or intends to become pregnant during the study period.
Note: the risks and benefits of performing the procedure if the subject is planning
future pregnancies should be carefully considered.

- Subject has had radiation therapy to the pelvic area.

- Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has
been on cytostatic medication within the past 12 months.

- Subject has a known hypersensitivity to the graft material(s).

- Subject has uncontrolled diabetes.

- Subject is on any medication which could result in compromised immune response, such
as immune modulators.

- Subject was involved in any other research trial < 30 days of enrollment into this
study.

- Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this
study.

- Subject is unwilling or unable to give valid informed consent.

- Subject is unwilling or unable to comply with the requirements of the protocol,
complete all Quality of Life questionnaires and return for all follow-up visits.

- Subject is contraindicated based on intended use and warnings in the AMS PFR System
devices for prolapse repair Instructions for Use (IFU).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • American Medical Systems
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    • Eastern Virginia Medical School
    • James C. Lukban, DO 
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    • Eastern Virginia Medical School
    • James C. Lukban, DO 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.