None listed
Conditions
Interventions
Medical Device : Patients who meet the selection criteria will be assigned according to the randomization table. On the day of surgery, the test group is transplanted MegaNerve Prime® to the target pa
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over 19 to under 80 years of age 2) Patients scheduled to undergo direct to implant (DTI) for breast cancer 3) Patients who agree to a clinical study and can follow up during the trial period 4) Patients with peripheral nerve damage or nerve defect due to disease and trauma
Exclusion criteria
Exclusion criteria: 1) Patients undergoing chemotherapy for cancer other than breast cancer 2) Patients with confirmed local recurrence or systemic metastasis of breast cancer 3) Patients with a history of ipsilateral breast surgery 4) Patients with underlying diseases such as infectious diseases, autoimmune diseases (especially rheumatic diseases, etc.), and blood clotting disorders 5) Patients with systemic diseases other than breast cancer (especially uncontrolled diabetes, etc.) 6) Pregnant or lactating women 7) Other patients who are judged to be difficult to participate in the research by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Semmes Weinstein Monofilaments(SWMF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Semmes Weinstein Monofilaments(SWMF);BREAST-Q Assessment;Sensory satisfaction assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactDongwon Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed