Status:
COMPLETED
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
Lead Sponsor:
pfm medical gmbh
Conditions:
Breast Reconstruction After Mastectomy
Breast Neoplasm
Eligibility:
FEMALE
18+ years
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 polyp...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT03868514
Start Date
July 4 2019
End Date
November 15 2023
Last Update
November 18 2023
Active Locations (12)
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1
Universitätsklinik für Frauenheilkunde, Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, 1090
2
Vivantes Klinikum Am Urban
Berlin, Germany, 10967
3
DRK Kliniken Westend
Berlin, Germany, 14050
4
Universitätsklinikum Bonn
Bonn, Germany, 53127