Post Market Clinical Follow Up to Patient Reported Outcome Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)

Study Overview
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Brief Summary
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PRO-Pocket - International prospective multicentre Post Market Clinical Follow Up to Patient reported outcome in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)

Detailed Description
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This international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on TiLOOP® Bra Pocket surgical meshes for a period of up to two years. In particular, on patient reported satisfaction (BreastQTM), cosmetic outcome and the rate of complications. The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket. The Investigation will be performed in ten clinical centres in Germany and Austria.

Official Title
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PRO-Pocket - International Prospective Multicenter Post Market Clinical Follow Up to Patient Reported Outcome in Primary or Secondary Breast Reconstruction After Mastectomy Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)

Conditions
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Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases

Intervention / Treatment
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* Device: TiLOOP® Bra Pocket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age [≥ 18] Indications of breast reconstruction: histologically confirmed breast cancer, precancerous lesions (DCIS, LCIS), mutation carrier with increased breast cancer risk, strong family history (lifetime risk > 15%) The patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1) Patient information has been provided and all written consents of the patient are available Exclusion Criteria: Metastatic breast cancer Patient with known contraindications against mesh-assisted or plastic-reconstructive breast surgery according to the instruction for use Patient is kept in an institution under judicial or official orders (MPG §20.3) Participate in another operative clinical trial, if it relates to the area of reconstructive breast surgery and/or influences the primary endpoint of the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TiLOOP Bra Pocket<br>Medical Device | Device: TiLOOP® Bra Pocket<br>* Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - Patient reported outcome | The primary endpoint is defined as the change of the four BreastQ domain scores before study treatment compared to twelve months after study treatment. The BreastQ questionnaire yields a domain score in the range from zero to 100. Wheras a score of 100 is the best score. The study hypothesis is that the patient's QoL after the study intervention treatment is not worse than the QoL prior to the intervention study treatment . The following four domains are relavant: Satisfaction with breasts, Psychosocial well-being, Physical well-being:chest and Sexual well-being. | 12 months after study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - Patient reported outcome | The change of the four BreastQ domain scores before study treatment compared to six months and 24 months after study treamtment. | 6 and 24 months after study treatment | 
| Complication rate | The number and rate of occurrence of adverse events is reported as a secondary endpoint along with a tabulation of the types of adverse events (6, 12 and 24 months after study treatment). | 6, 12 and 24 months after study treatment | 
| Cosmetic outcome | The cosmetic outcome is assessed based on photographs 6, 12 and 24 months after study treatment by descriptive statistics (an independent expert, the physician in charge and the patient assess the cosmetic outcome). | 6, 12 and 24 months after study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, surgical mesh, synthetic mesh, patient reported outcome, breast cancer, mesh