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evaluation safety and efficacy of nerve allograft MegaNerve Prime® in breast reconstructio

Not Applicable
Conditions
Neoplasms
Registration Number
KCT0008208
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
40
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

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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Semmes Weinstein Monofilaments(SWMF)
Secondary Outcome Measures
NameTimeMethod
Semmes Weinstein Monofilaments(SWMF);BREAST-Q Assessment;Sensory satisfaction assessment
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