Clinical trial NCT03868514: Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
Official title: "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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction After Mastectomy
Breast Neoplasm
Breast Cancer
Breast Diseases
Keywords: breast reconstruction
surgical mesh
synthetic mesh
patient reported outcome
breast cancer
mesh
Lead sponsor: pfm medical gmbh
Sponsor class: INDUSTRY
First posted: 2019-03-11
Enrollment: 313
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with indicated implant based breast reconstruction after mastectomy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life - Patient reported outcome
timeFrame: 12 months after study treatment
Secondary outcomes:
measure: Quality of Life - Patient reported outcome
timeFrame: 6 and 24 months after study treatment
measure: Complication rate
timeFrame: 6, 12 and 24 months after study treatment
measure: Cosmetic outcome
timeFrame: 6, 12 and 24 months after study treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Berlin
country: Germany
facility: DRK Kliniken Westend
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Essen
country: Germany
facility: Kliniken Essen Mitte; Evang. Huyssens-Stiftung
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Munich
country: Germany
facility: Rotkreuzklinikum München
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Weinheim
country: Germany
facility: GRN Klinik Weinheim
Study officials:
References: