National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra (PRO-BRA)

pfm medical

Status

Completed

Conditions

Breast Reconstruction After Mastectomy

Treatments

Device: TiLOOP Bra

Study type

Interventional

Funder types

Industry

Identifiers

NCT01885572

pfm 12k001 TiLOOP Bra

Details and patient eligibility

About

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.

Enrollment

267 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No 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 exclusion criteria (contraindications):

Pathological or physical condition precluding such as:

Pregnancy or breast-feeding patients
Known intolerance to the mesh-implants under investigation.

Study-related exclusion criteria - Medical reasons:

metastatic breast cancer
medicamentous regulated diabetes with blood sugar level >250
inadequate bone marrow function with neutrophil granulocytes <1500 and blood plates < 10000/µl
patient with known contraindication to mesh-implants or plastic-reconstructive breast operations

Study-related exclusion criteria - Legal reasons:

Lack of written patients informed consent.
Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
Patient is institutionalized by court or official order (MPG§20.3).
Participation in another operative clinical investigation.

It is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation.