National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra (PRO-BRA)
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.
The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)|
- PRO [ Time Frame: 12 months after breast reconstruction ] [ Designated as safety issue: No ]Measurement of the Patient Reported Outcome (PRO).
- PRO [ Time Frame: 6 and 24 months after breast reconstruction ] [ Designated as safety issue: No ]Measurement of the Patient Reported Outcome
- Complication Rate [ Time Frame: after 6, 12 and 24 months ] [ Designated as safety issue: Yes ]Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.
- Cosmetic Success [ Time Frame: 6, 12 and 24 months after breast reconstruction ] [ Designated as safety issue: No ]Cosmetic success confirming the reinforcement will be assessed by the patient and an independent professional at a photo. The questions posed are part of the validated Breast Q questionnaire.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Treatment with TiLOOP Bra
Device: TiLOOP Bra
Titaniferously coated polypropylene mesh
|Contact: Sabrina Tofallfirstname.lastname@example.org|
|Helios Kliniken||Not yet recruiting|
|Berlin, Germany, 13125|
|Principal Investigator: Christine Mau, Dr.|
|Vivantes Kliniken am Urban||Not yet recruiting|
|Berlin, Germany, 10967|
|Principal Investigator: Andree Faridi, Prof. Dr.|
|St. Gertrauden Krankenhaus||Not yet recruiting|
|Berlin, Germany, 10713|
|Principal Investigator: Jens-Uwe Blohmer, Prof. Dr.|
|Agaplesion Markus Krankenhaus||Not yet recruiting|
|Frankfurt am Main, Germany, 60431|
|Principal Investigator: Marc Thill, Dr.|
|St. Elisabeth Krankenhaus||Not yet recruiting|
|Koeln, Germany, 50935|
|Principal Investigator: Anette Meire, Dr.|
|Muenchen, Germany, 81675|
|Principal Investigator: Stefan Paepke, Dr.|
|Universitätsfrauenklinik||Not yet recruiting|
|Rostock, Germany, 18057|
|Principal Investigator: Max Dieterich, Dr.|
|Principal Investigator:||Stefan Paepke, MD||Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany|