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

NCT01885572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2021-09-20

No results posted yet for this study

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.

Conditions

  • Breast Reconstruction After Mastectomy

Interventions

DEVICE

TiLOOP Bra

Titaniferously coated polypropylene mesh

Sponsors & Collaborators

  • pfm medical gmbh

    collaborator INDUSTRY

  • Pfm Medical Mepro Gmbh

    lead INDUSTRY

Principal Investigators

  • Stefan Paepke, MD · Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-08-31
Completion
2021-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01885572 on ClinicalTrials.gov