Evaluating sensation and satisfaction in cancer and transgender mastectomy patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess postoperative sensation and patient-reported outcomes in individuals undergoing gender-affirming mastectomy and breast reconstruction. It compares patients who receive advanced surgical reinnervation techniques to those who do not, focusing on the impact of these techniques on sensation and satisfaction. The study employs quantitative sensory testing to measure various aspects of sensation, addressing limitations in previous research. By utilizing a standardized approach, the study seeks to provide comprehensive insights into the effectiveness of nerve preservation and grafting during mastectomy procedures.

Why it matters

Who can join: the full rules

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)

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Lisa Gfrerer, MD, PhD — Weill Medical College of Cornell University
• Study coordinator: Lisa Gfrerer, MD, PhD
• Email: lig4013@med.cornell.edu
• Phone: 646.962.4250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.