Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06094257

Conditions

Sensation Disorders

Sensation, Phantom

Pain, Postoperative

Pain, Chronic

Numbness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sensory testing

Study Details

Brief summary:

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

Sensation Disorders

Sensation, Phantom

Pain, Postoperative

Pain, Chronic

Numbness

Study ID

NCT06094257

Start date

Feb 9, 2022

Status verified date

Aug, 2025

Completion date

Mar, 2033

Anticipated

Primary completion date

Mar, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Nipple sparing mastectomy (NSM) and implant reconstruction

Nipple sparing mastectomy (NSM) and implant reconstruction

Nipple sparing mastectomy (NSM) and autologous reconstruction

Nipple sparing mastectomy (NSM) and autologous reconstruction

Gender mastectomy with free nipple grafting

Gender mastectomy with free nipple grafting

Control patients matched by surgical procedure, age, BMI and mastectomy weight.

Control patients matched by surgical procedure, age, BMI and mastectomy weight.

Interventions

Sensory testing

Quantitative sensory testing (QST) will be performed. QST was developed to standardize the noninvasive assessment of the somatosensory nervous system and quantify functioning of all aspects of sensation (light touch, pressure, warm, cold, pain, vibration): 1. Thermal detection (Medoc TSA system): Cold detection threshold B) Warm detection threshold C) Heat pain threshold 2. Mechanical detection threshold (MRC Opti Hair von Frey Filaments) 3. Two-point discrimination (MRC Opti Hair von Frey Filaments) 4. Mechanical pain threshold (MRC Pinprick Stimulator) 5. Pressure pain threshold (Medoc Pressure algometer) 6. Tinel sign on physical exam 7. Vibration (tuning fork)

Primary outcome measure

  • Change in Breast Q scores [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in Gender-Q scores [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in cold detection threshold [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in warm detection threshold [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in heat pain threshold [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in mechanical detection threshold [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in two-point discrimination [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in mechanical pain threshold [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in pressure pain threshold [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in Tinel sensation [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]
  • Change in vibration sensation [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]

Central Contacts and Locations

Central contacts

Lisa Gfrerer, MD, PhD

646.962.4250lig4013@med.cornell.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Lisa Gfrerer, MD. PhD

(646) 962-2330lgfrerer@partners.org

Principal Investigator:

Lisa Gfrerer, MD, PhD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Lisa Gfrerer, MD, PhD

646.962.4250lig4013@med.cornell.edu

Principal Investigator:

Lisa Gfrerer, MD, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Keywords

  • Sensation
  • Reinnervation
  • Peripheral nerve
  • Reconstruction
  • Breast reinnervation
  • Chest reinnervation
  • Gender-affirming mastectomy
  • Breast reconstruction
  • Peripheral nerve repair
  • Targeted nipple areolar complex
  • Targeted nipple areolar complex reinnervation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-08-27.