Clinical trial NCT01885572: National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
Official title: National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Reconstruction After Mastectomy
Keywords: breast reconstruction
mastectomy
mesh
breast cancer
Lead sponsor: Pfm Medical Mepro Gmbh
Sponsor class: INDUSTRY
Collaborators: name: pfm medical gmbh
First posted: 2013-06-25
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.

The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.


Eligibility criteria: Inclusion Criteria:

The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. Patients shall be included if they meet all of the following criteria:

Clinical Criteria (reason):

* women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant
* women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history
* the health of women must comply with ECOG (Eastern Cooperative Oncology Group) performance status 0-2

Study-related inclusion criteria - Legal reasons:

* Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
* Patient information has been handed out and all written consents are at hand.
* Patient is between 18 and 70 years old.

Exclusion Criteria:

Patients must be excluded if any of the following conditions exist or cannot be excluded:

Device-related exclusion criteria (contraindications):

Pathological or physical condition precluding such as:

* Pregnancy or breast-feeding patients
* Known intolerance to the mesh-implants under investigation.

Study-related exclusion criteria - Medical reasons:

* metastatic breast cancer
* medicamentous regulated diabetes with blood sugar level \>250
* inadequate bone marrow function with neutrophil granulocytes \<1500 and blood plates \< 10000/µl
* patient with known contraindication to mesh-implants or plastic-reconstructive breast operations

Study-related exclusion criteria - Legal reasons:

* Lack of written patients informed consent.
* Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
* Patient is institutionalized by court or official order (MPG§20.3).
* Participation in another operative clinical investigation.

It is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation.

Primary outcomes:
measure: PRO
timeFrame: 12 months after breast reconstruction
Secondary outcomes:
measure: PRO
timeFrame: 6 and 24 months after breast reconstruction
measure: Complication Rate
timeFrame: after 6, 12 and 24 months
measure: Cosmetic Success
timeFrame: 6, 12 and 24 months after breast reconstruction
measure: PRO and Complication Rate
timeFrame: 48 months after breast reconstruction
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Campus Mitte and Benjamin Franklin
city: Berlin
country: Germany
facility: St. Gertrauden Krankenhaus
city: Berlin
country: Germany
facility: Vivantes Kliniken am Urban
city: Berlin
country: Germany
facility: Helios Kliniken
city: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Koeln
country: Germany
facility: St. Elisabeth Krankenhaus
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde
city: Muenchen
country: Germany
facility: Technische Universität
Study officials:
affiliation: Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany
name: Stefan Paepke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thill M, Faridi A, Meire A, Gerber-Schafer C, Baumann K, Blohmer JU, Mau C, Tofall S, Nolte E, Strittmatter HJ, Ohlinger R, Paepke S. Patient reported outcome and cosmetic evaluation following implant-based breast-reconstruction with a titanized polypropylene mesh (TiLOOP(R) Bra): A prospective clinical study in 269 patients. Eur J Surg Oncol. 2020 Aug;46(8):1484-1490. doi: 10.1016/j.ejso.2020.04.009. Epub 2020 Apr 15.
citation: Nolte E, Klein E, Paepke S. Pregnancy following Unilateral Immediate Breast Reconstruction with Titanized Polypropylene Mesh (TiLOOP(R) Bra) without Compromising the Result. Plast Reconstr Surg Glob Open. 2018 Sep 14;6(9):e1919. doi: 10.1097/GOX.0000000000001919. eCollection 2018 Sep.