Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients

RecruitingObservational studyHealthy volunteers welcome

Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility criteria

Inclusion Criteria:

* Age over 18
* Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction
* Patient is capable and willing to provide informed consent

Exclusion Criteria:

* Patient has a nerve condition that does not allow for assessment of sensation
* Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
* Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
* Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)

About the study

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.

What is being tested

Sensory testing (diagnostic test)

Sponsor: Weill Medical College of Cornell University · Participants: 400 · Started: Feb 9, 2022

Contact the study team

Lisa Gfrerer, MD, PhD · Phone: 646.962.4250

Official record on ClinicalTrials.gov — NCT06094257

Locations in the U.S.

Massachusetts	Massachusetts General Hospital, Boston
New York	Weill Cornell Medicine, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.