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National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)


N/A
18 Years
75 Years
Not Enrolling
Female
Breast Reconstruction After Mastectomy

Thank you

Trial Information

National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)


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 75 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PRO

Outcome Description:

Measurement of the Patient Reported Outcome (PRO).

Outcome Time Frame:

12 months after breast reconstruction

Safety Issue:

No

Principal Investigator

Stefan Paepke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Technical University Munich, Ismaningerstrasse 22, 81675 Munich, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

pfm 12k001 TiLOOP Bra

NCT ID:

NCT01885572

Start Date:

August 2013

Completion Date:

February 2015

Related Keywords:

  • Breast Reconstruction After Mastectomy
  • breast reconstruction
  • mastectomy
  • mesh
  • breast cancer

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