NCT01885572

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Pfm Medical Mepro Gmbh · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	TiLOOP Bra	Titaniferously coated polypropylene mesh

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-08-01
• Completion: 2021-06-01
• First posted: 2013-06-25
• Last updated: 2021-09-20

Locations

8 sites across 1 country: Germany