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Post-Market Clinical Follow-Up - TiLOOP® Bra Pocket

Post-Market Clinical Follow-Up - TiLOOP® Bra Pocket - PMCFU BRA Pocket

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00014800
Enrollment
150
Registered
2018-05-30
Start date
2017-11-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: Questionnaire regarding TiLOOP Bra Pocket, all patients required for this surgical procedure in the site could be enclosed.

Sponsors

pfm medical ag
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Prepectoral, muscle preserving, implant based breast reconstruction with the support of TiLOOP® Bra Pocket

Exclusion criteria

Exclusion criteria: Pregnancy or breast-feeding patients, Known intolerance to the mesh-implants under investigation

Design outcomes

Primary

MeasureTime frame
The aims are to determine if size selection, placing of the implant in the pocket and fixation were easy to perform,to evaluate the fixation points used to suture the device to the pectoralis major muscle, to determine the occurrence and kind of complications and to evaluate the cosmetic outcome postoperatively as assessed by the surgeon

Secondary

MeasureTime frame
Determination if size selection, placing of the implant in the pocket and fixation were easy to perform, Evaluation of the fixation points used to suture the device to the pectoralis major muscle, Determination of the occurrence and kind of complications, Evaluation of the cosmetic outcome postoperatively as assessed by the surgeon

Countries

Austria, Germany, Spain, Switzerland, United Kingdom

Contacts

Public ContactKatharina Müller

pfm medical ag

katharina.mueller@pfmmedical.com02236 9641 259

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026