National, Multicenter PMS Study Patient Reported Outcome in Breast Reconstruction Following Mastectomy With TiLOOP Bra

Study Overview
=================
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.

Official Title
-----------------
National, Multicenter Post-market Surveillance Study Patient Reported Outcome in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)

Conditions
-----------------
Breast Reconstruction After Mastectomy

Intervention / Treatment
-----------------
* Device: TiLOOP Bra


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TiLOOP Bra<br>Treatment with TiLOOP Bra | Device: TiLOOP Bra<br>* Titaniferously coated polypropylene mesh<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRO | Measurement of the Patient Reported Outcome | 6 and 24 months after breast reconstruction | 
| Complication Rate | Complication rate of the first 60 patients in the 6 month follow-up and of all patients after 6, 12 and 24 months. | after 6, 12 and 24 months | 
| Cosmetic Success | 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. | 6, 12 and 24 months after breast reconstruction | 
| PRO and Complication Rate | Measurement of the Patient Reported Outcome and complication rate of all patients | 48 months after breast reconstruction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast reconstruction, mastectomy, mesh, breast cancer