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

Weill Medical College of Cornell University · with Massachusetts General Hospital · NCT06094257

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
400
US sites recruiting
2
Study start
February 9, 2022
Record last updated
September 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Sensory testing

Conditions: Sensation Disorders; Sensation, Phantom; Pain, Postoperative; Pain, Chronic; Numbness; Sensory Disorder; Sensory Defect; Phantom Pain; Phantom Sensation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Lisa Gfrerer, MD. PhD · (646) 962-2330 · lgfrerer@partners.org

  • Weill Cornell Medicine

    New York, NY 10065

    Site contact: Lisa Gfrerer, MD, PhD · 646.962.4250 · lig4013@med.cornell.edu

Study contacts (from the official record)

  • Lisa Gfrerer, MD, PhD · 646.962.4250 · lig4013@med.cornell.edu
All pain studies in Massachusetts →
Prospective Study of Sensation and Satisfaction in Cancer and… (NCT06094257) | Bored Studies