Status:
NOT_YET_RECRUITING
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
Lead Sponsor:
George Kokosis
Conditions:
Post-mastectomy Pain Syndrome
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. In the...
Eligibility Criteria
Inclusion
- Adult female 18 to 65 years of age.
- Undergoing breast mastectomy with immediate reconstruction.
- Able to provide informed consent and comply with study procedures.
Exclusion
- History of chronic pain syndrome unrelated to breast surgery.
- Unwillingness or inability to comply with the study's follow-up requirements.
- Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments.
- Participation in other interventional trials or treatments aimed at pain management that could confound study outcomes as determined by the PI.
- Other medical or surgical contraindication to the involved procedure (RPNI) as determined by the PI.
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06580951
Start Date
March 1 2026
End Date
March 1 2030
Last Update
December 30 2025
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