Trial document




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  DRKS00005342

Trial Description

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Title

„PRO-BRA“ - National, multicenter post-market surveillance study „Patient Reported Outcome“ in breast reconstruction following mastectomy with titaniferously coated polypropylene mesh (TiLOOP® Bra)

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Trial Acronym

PRO-BRA

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URL of the Trial

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Brief Summary in Lay Language

It is a clinical study with the CE-marked titaniferously coated polypropylene mesh TiLOOP Bra. It is intended for the support, reinforcement and bridging of body´s own tissue in reconstructive and plastic-aesthetic breast surgery, e. g breast cancer.

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Brief Summary in Scientific Language

National, multicenter, post-market surveillance study in breast reconstruction after mastectomy with titaniferously coated polypropylene mesh TiLOOP Bra.

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Organizational Data

  •   DRKS00005342
  •   2014/01/08
  •   2013/05/24
  •   no
  •   Approved
  •   5890/13, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   NCT01885572  (www.clinicaltrial.gov)
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Treatment with TiLOOP Bra
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Measurement of the Patient Reported Outcome (Quality of life) 12 months after breast reconstruction with the Breast-Q questionnaire.

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Secondary Outcome

- Measurement of the Patient Reported Outcome 6 and 24 months after breast reconstruction (Breast-Q Questionnaire).
- Complication rate of the first 60 patients int he 6 month follow-up and of all patients after 6, 12, and 24 months.
- Cosmetic success after 6, 12 and 24 months (an independent expert evaluates pictures of the breast).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/12/27
  •   267
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

- women with indication for prophylactic operation or oncoplastic operation with support of a mesh implant
- women with histologically confirmed breast cancer or precanzerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history
- the health of women must comply with ECOG performance status 0-2
Study-related inclusion criteria - Legal reasons:
- Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
- Patient information has been handed out and all written consents are at hand.

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Exclusion Criteria

- Pregnancy or breast-feeding patients
- Known intolerance to the mesh-implants under investigation
- metastatic breast cancer
- medicamentous regulated diabetes mellitus with blood sugar level >250
- inadequate bone marrow function with neutrophil granulocytes <1500 and blood plates < 100.000/µl
- patient with known contraindication to mesh-implants or plastic-reconstructive breast operations
- Lack of written patients informed consent.
- Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- Patient is institutionalized by court or official order (MPG§20.3).
- Participation in another operative clinical investigation.

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Addresses

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    • pfm medical ag
    • Wankelstraße 60
    • 50996  Köln
    • Germany
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    • pfm medical ag
    • Ms.  Katja  Klein 
    • Wankelstraße 60
    • 50996  Köln
    • Germany
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    • pfm medical ag
    • Ms.  Katja  Klein 
    • Wankelstraße 60
    • 50996  Köln
    • Germany
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Sources of Monetary or Material Support

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    • pfm medical ag
    • Wankelstraße 60
    • 50996  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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