Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06094257

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here