NCT06094257 Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
| NCT ID | NCT06094257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Sensation Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-02-09 |
| Primary Completion | 2033-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-02-09 with a primary completion date of 2033-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Lisa Gfrerer, MD, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06094257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sensation Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06094257 currently recruiting?
Yes, NCT06094257 is actively recruiting participants. Contact the research team at lig4013@med.cornell.edu for enrollment information.
Where is the NCT06094257 trial being conducted?
This trial is being conducted at Boston, United States, New York, United States.
Who is sponsoring the NCT06094257 clinical trial?
NCT06094257 is sponsored by Weill Medical College of Cornell University. The principal investigator is Lisa Gfrerer, MD, PhD at Weill Medical College of Cornell University. The trial plans to enroll 400 participants.