Spots Global Cancer Trial Database for National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
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Trial Identification
Brief Title: National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
Official Title: National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)
Study ID: NCT01885572
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Charite Campus Mitte and Benjamin Franklin, Berlin, , Germany
St. Gertrauden Krankenhaus, Berlin, , Germany
Vivantes Kliniken am Urban, Berlin, , Germany
Helios Kliniken, Berlin, , Germany
Agaplesion Markus Krankenhaus, Frankfurt am Main, , Germany
St. Elisabeth Krankenhaus, Koeln, , Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde, Lübeck, , Germany
Technische Universität, Muenchen, , Germany
Contact Details
Name: Stefan Paepke, MD
Affiliation: Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany
Role: PRINCIPAL_INVESTIGATOR
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