National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra (PRO-BRA)
|ClinicalTrials.gov Identifier: NCT01885572|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2013
Last Update Posted : April 28, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Reconstruction After Mastectomy||Device: TiLOOP Bra|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||267 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2018|
Treatment with TiLOOP Bra
Device: TiLOOP Bra
Titaniferously coated polypropylene mesh
- PRO [ Time Frame: 12 months after breast reconstruction ]Measurement of the Patient Reported Outcome (PRO).
- PRO [ Time Frame: 6 and 24 months after breast reconstruction ]Measurement of the Patient Reported Outcome
- Complication Rate [ Time Frame: after 6, 12 and 24 months ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885572
|Charite Campus Mitte and Benjamin Franklin|
|Berlin, Germany, 10117|
|St. Gertrauden Krankenhaus|
|Berlin, Germany, 10713|
|Vivantes Kliniken am Urban|
|Berlin, Germany, 10967|
|Berlin, Germany, 13125|
|Klinik für Frauenheilkunde und Geburtshilfe der Universität|
|Agaplesion Markus Krankenhaus|
|Frankfurt am Main, Germany, 60431|
|St. Elisabeth Krankenhaus|
|Koeln, Germany, 50935|
|Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde|
|Muenchen, Germany, 81675|
|Principal Investigator:||Stefan Paepke, MD||Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany|