Trial document




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  DRKS00004924

Trial Description

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Title

Establishment of an algorithm to evaluate quality and function of silicone breast implants (in the context of the PIP-/Rofil-affair)

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Trial Acronym

Silicone-breast-implant-study

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URL of the Trial

http://none

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Brief Summary in Lay Language

Comparison of Silicone findings in blood and breast tissue of patients carrying silicone breast implants and correlation with findings in ultrasound or MRT to establish an algorithm for quality assessment and prevention of unnecessary explantation.
Aim: Establishing an algorithm for quality assessment (type of siloxane in and condition) of the silicone-breast-implant. Attempt to define a limit-value of silicone-content in blood which can be used to evaluate implant quality and condition.
secondary aim: Check of possibilities to prevent unneccessary implant-exchange-operations.
Method:
Participants: women of at least 18years of age with indication for removal or exchange of silicone-breast-implants.
Material: venous blood, tissue-probes from the implant-pocket inside the breast.
Method: Analysis of the Condition of the breast implant preoperative by medical imaging (Sonography, Mammography or MRT). Measuremt of Silicone-content in blood and tissue-probes from the breast by means of gas-chromatography.

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Brief Summary in Scientific Language

we try to find a reliable and cost-effective Instrument, which is minimal invasive to the Patient, to assess quality of silicone breast implants by comparison of ultrasound and Analysis of silicone-content in blood and breast-tissue.

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Organizational Data

  •   DRKS00004924
  •   2013/08/08
  •   [---]*
  •   yes
  •   Approved
  •   13-5384-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   T85.88 -  [generalization T85.8: Other complications of internal prosthetic devices, implants and grafts, not elsewhere classified]
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Interventions/Observational Groups

  •   One arm only. Participating are women of at least 18years age with medical indication for exchange or removal of silicone breast implants. Measurement of silicone-content in blood (preoperative) and tissue from the implant-pocket of the breast (intraoperative). Comparison of the findings in silicone-content of blood vs. tissue as well as those findings vs. preoperative clinical evaluation and clinical imaging (Sonography, Mammography or MRT).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Measurement of silicone-content in blood and tissue of the breast by means of gas-chromatography (Agilent Technologies 5973 Network: GC-distinction-column Restek Rxi-5sil MS30m x 250um x0,25um) and comparison with findings in medical imaging and clinical evidence.

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Secondary Outcome

- establishment of an algorithm to evaluate quality of silicone-breast-implants
- definition of a threshold value for blood-silicone-measured value
- testing of the options to avoid unneccessary implant-explantations

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/08/02
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Indication for exchange or removal of silicone breast implants.

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Exclusion Criteria

less than 18 years old, not able to agree

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Leiter Institut f. angewandte analyt. Chemie der Universität Essen-Duisburg
    • Mr.  Prof. Dr.  Oliver  Schmitz 
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    •   [---]*
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    • UFK Essen
    • Mr.  Dr. med.  Peter  Rusch 
    • Hufelandstr. 55
    • 45130   Essen
    • Germany
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    • UFK Essen
    • Mr.  Dr. med.  Peter  Rusch 
    • Hufelandstr. 55
    • 45147   Essen
    • Germany
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Sources of Monetary or Material Support

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    • Unifrauenklinik Essen
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    •   0201-723-0
    •   [---]*
    •   [---]*
    •   [---]*
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    • DFG-Antrag gestellt durch Institut für Angewandte Analytische Chemie, Prof. Dr. O. Schmitz, Verfahren laufend.
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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