Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

TiLOOP Bra

Stefan Paepke, MD

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.

National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra

National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

Measurement of the Patient Reported Outcome (PRO).

Measurement of the Patient Reported Outcome

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 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.

Measurement of the Patient Reported Outcome and complication rate of all patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra	NCT01885572	Breast Reconstr...	TiLOOP Bra	18 Years - 70 Years	Pfm Medical Mepro Gmbh
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra	NCT01885572	Breast Reconstr...	TiLOOP Bra	18 Years - 70 Years	Pfm Medical Mepro Gmbh

Spots Global Cancer Trial Database for breast reconstruction after mastectomy