Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfm Medical Mepro Gmbh
With
pfm medical gmbh
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
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.
You may not be if
Patients must be excluded if any of the following conditions exist or cannot be excluded:
Pathological or physical condition precluding such as:
Pregnancy or breast-feeding patients
Known intolerance to the mesh-implants under investigation.
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
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.
Clareo Health | National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
