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

pfm medical gmbh313 enrolled

Overview

"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)

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.

Study Type

OBSERVATIONAL

Enrollment

313

Conditions

Breast Reconstruction After Mastectomy Breast Neoplasm Breast Cancer Breast Diseases

Interventions

TiLOOP® Bra PocketDEVICE

Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (12)

Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

Vivantes Klinikum Am Urban

Berlin, Germany

DRK Kliniken Westend

Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: 12 months after study treatment

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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).

Time frame: 6, 12 and 24 months after study treatment

Data from ClinicalTrials.gov

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