Actively Recruiting
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Led by Weill Medical College of Cornell University · Updated on 2025-08-27
400
Participants Needed
2
Research Sites
576 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.
CONDITIONS
Official Title
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18
- Scheduled for gender mastectomy surgery including nipple sparing mastectomy or mastectomy with free nipple graft
- Scheduled for nipple sparing mastectomy with breast implant or autologous reconstruction
- Capable and willing to provide informed consent
You will not qualify if you...
- Presence of a nerve condition preventing assessment of sensation
- Investigator determines patient is unsuitable or unlikely to comply with follow-up
- Currently prescribed medication known to impact nerve regeneration or cause peripheral neuropathy
- Bilateral reconstruction with non-uniform treatment (one breast neurotized, the other not)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
L
Lisa Gfrerer, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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