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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
267
Titaniferously coated polypropylene mesh
Charite Campus Mitte and Benjamin Franklin
Berlin, Germany
St. Gertrauden Krankenhaus
Berlin, Germany
Vivantes Kliniken am Urban
Berlin, Germany
Helios Kliniken
Berlin, Germany
PRO
Measurement of the Patient Reported Outcome (PRO).
Time frame: 12 months after breast reconstruction
PRO
Measurement of the Patient Reported Outcome
Time frame: 6 and 24 months after breast reconstruction
Complication Rate
Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.
Time frame: after 6, 12 and 24 months
Cosmetic Success
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.
Time frame: 6, 12 and 24 months after breast reconstruction
PRO and Complication Rate
Measurement of the Patient Reported Outcome and complication rate of all patients
Time frame: 48 months after breast reconstruction
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St. Elisabeth Krankenhaus
Cologne, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde
Lübeck, Germany
Technische Universität
München, Germany