NCT03868514

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

"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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 313 (actual)
• Sponsor: pfm medical gmbh · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Detailed 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.

Conditions

• Breast Reconstruction After Mastectomy
• Breast Neoplasm
• Breast Cancer
• Breast Diseases

Interventions

Type	Name	Description
DEVICE	TiLOOP® Bra Pocket	Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket

Timeline

• Start date: 2019-07-04
• Primary completion: 2022-06-22
• Completion: 2023-11-15
• First posted: 2019-03-11
• Last updated: 2023-11-18

Locations

12 sites across 2 countries: Austria, Germany