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

Completed

• Conditions: Breast Cancer; Breast Diseases; Breast Reconstruction After Mastectomy; Breast Neoplasm
• Interventions: Device: TiLOOP® Bra Pocket

• Registration Number: NCT03868514
• Lead Sponsor: pfm medical gmbh

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.

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-11
• Study Start: 2019-07-04
• Primary Completion: 2022-06-22
• Status Verified: 2023-11
• Study Completion: 2023-11-15
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 313

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TiLOOP Bra Pocket	TiLOOP® Bra Pocket	Medical Device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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).

Trial Locations

Locations (12)

Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Vienna, Austria

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Agaplesion Markus Krankenhaus; 🇩🇪 Frankfurt, Germany

Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Germany

Universitätsmedizin Greifswald; 🇩🇪 Greifswald, Germany

Vivantes Klinikum Am Urban; 🇩🇪 Berlin, Germany

Rotkreuzklinikum München; 🇩🇪 Munich, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

GRN Klinik Weinheim; 🇩🇪 Weinheim, Germany

DRK Kliniken Westend; 🇩🇪 Berlin, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Kliniken Essen Mitte; Evang. Huyssens-Stiftung; 🇩🇪 Essen, Germany