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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01885572

Acronym

PRO-BRA

Enrollment

267

Registered

2013-06-25

Start date

2013-11-30

Completion date

2021-06-30

Last updated

2021-09-20

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

Conditions

Breast Reconstruction After Mastectomy

Keywords

breast reconstruction, mastectomy, mesh, breast cancer

Brief 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.

Interventions

DEVICETiLOOP Bra

Titaniferously coated polypropylene mesh

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. Patients shall be included if they meet all of the following criteria: Clinical Criteria (reason): * women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant * women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history * the health of women must comply with ECOG (Eastern Cooperative Oncology Group) performance status 0-2 Study-related inclusion criteria - Legal reasons: * Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation * Patient information has been handed out and all written consents are at hand. * Patient is between 18 and 70 years old.

Exclusion criteria

Patients must be excluded if any of the following conditions exist or cannot be excluded: Device-related

Design outcomes

Primary

Measure	Time frame	Description
PRO	12 months after breast reconstruction	Measurement of the Patient Reported Outcome (PRO).

Secondary

Measure	Time frame	Description
PRO	6 and 24 months after breast reconstruction	Measurement of the Patient Reported Outcome
Complication Rate	after 6, 12 and 24 months	Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months.
Cosmetic Success	6, 12 and 24 months after breast reconstruction	Cosmetic success confirming the reinforcement will be assessed by the patient and an independent professional at a photo. The questions posed are part of the validated Breast Q questionnaire.
PRO and Complication Rate	48 months after breast reconstruction	Measurement of the Patient Reported Outcome and complication rate of all patients

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026