Breast Cancer, Breast Diseases, Breast Neoplasm, Breast Reconstruction After Mastectomy
Conditions
Keywords
breast reconstruction, surgical mesh, synthetic mesh, patient reported outcome, breast cancer, mesh
Brief summary
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
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.
Interventions
DEVICETiLOOP® Bra Pocket
Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket
Sponsors
pfm medical gmbh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - Patient reported outcome | 12 months after study treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - Patient reported outcome | 6 and 24 months after study treatment | The change of the four BreastQ domain scores before study treatment compared to six months and 24 months after study treamtment. |
| Complication rate | 6, 12 and 24 months after study treatment | 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). |
| Cosmetic outcome | 6, 12 and 24 months after study treatment | 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). |
Countries
Austria, Germany
Outcome results
None listed