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Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket) — PRO-Pocket  

Breast Cancer Clinical Trial

Official title:
"PRO-Pocket" - International Prospective Multicenter Post Market Clinical Follow Up to "Patient Reported Outcome" in Primary or Secondary Breast Reconstruction After Mastectomy Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)

Clinical Trial Summary

"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)

Clinical Trial Description

This international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on TiLOOP® Bra Pocket surgical meshes for a period of up to two years. In particular, on patient reported satisfaction (BreastQTM), cosmetic outcome and the rate of complications. The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket. The Investigation will be performed in ten clinical centres in Germany and Austria. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03868514
Study type Observational
Source pfm medical ag
Contact
Status Completed
Phase
Start date July 4, 2019
Completion date November 15, 2023
View Details
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