Status:
NOT_YET_RECRUITING
The Role of Amnion Membrane Allografts in Nipple Preservation
Lead Sponsor:
Stanford University
Conditions:
Mastectomy
Gender Affirmation Surgery
Eligibility:
All Genders
15-75 years
Phase:
NA
Brief Summary
The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viab...
Detailed Description
This proposal will be the first clinical trial to evaluate the clinical efficacy of dHACM allografts in NSM. The topic of study not only addresses a critically unmet need in the field of plastic surge...
Eligibility Criteria
Inclusion
- Biologically female with documented diagnosis of gender dysphoria, desire to undergo gender affirming surgery (female-to-male) NSM, and age 15 years of age or older.
- Biological female, age 18 to 75 years old, who desire to undergo bilateral prophylactic NSM for nonmalignant breast conditions or to reduce the risk of breast cancer.
Exclusion
- Current steroid use
- Known connective tissue disorder
- Known neuropathy
- Known history of breast cancer
- History of breast radiotherapy
- Pregnant or nursing
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06073808
Start Date
January 1 2026
End Date
September 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
Division of Plastic & Reconstructive Surgery
Palo Alto, California, United States, 94304