Status:
COMPLETED
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
Lead Sponsor:
Pfm Medical Mepro Gmbh
Collaborating Sponsors:
pfm medical gmbh
Conditions:
Breast Reconstruction After Mastectomy
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT01885572
Start Date
November 1 2013
End Date
June 1 2021
Last Update
September 20 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Charite Campus Mitte and Benjamin Franklin
Berlin, Germany, 10117
2
St. Gertrauden Krankenhaus
Berlin, Germany, 10713
3
Vivantes Kliniken am Urban
Berlin, Germany, 10967
4
Helios Kliniken
Berlin, Germany, 13125