[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523328":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":70,"collaborators":72,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":99,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,13,16,19],{"label":9,"type":10,"description":9,"interventionNames":11},"Nipple sparing mastectomy (NSM) and implant reconstruction",null,[12],"Diagnostic Test: Sensory testing",{"label":14,"type":10,"description":14,"interventionNames":15},"Nipple sparing mastectomy (NSM) and autologous reconstruction",[12],{"label":17,"type":10,"description":17,"interventionNames":18},"Gender mastectomy with free nipple grafting",[12],{"label":20,"type":10,"description":20,"interventionNames":21},"Control patients matched by surgical procedure, age, BMI and mastectomy weight.",[12],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","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)",[20,17,14,9],[29],{"name":30,"affiliation":5,"role":31},"Lisa Gfrerer, MD, PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","646.962.4250","lig4013@med.cornell.edu",[38,58],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Massachusetts General Hospital","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":10,"email":56},"Lisa Gfrerer, MD. PhD","(646) 962-2330","lgfrerer@partners.org",{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"facility":59,"status":40,"city":60,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Weill Cornell Medicine","New York","10065",{"type":47,"coordinates":63},[64,65],-74.00597,40.71427,{"lat":65,"lon":64},[68,69],{"name":30,"role":34,"phone":35,"phoneExt":10,"email":36},{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"type":71,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[73],{"name":39,"class":6},"100523328","prospective-study-of-sensation-and-satisfaction-in-cancer-and-transgender-mastectomy-patients-100523328",false,"NCT06094257","Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients","Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.","Inclusion Criteria:\n\n* Age over 18\n* 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\n* Patient is capable and willing to provide informed consent\n\nExclusion Criteria:\n\n* Patient has a nerve condition that does not allow for assessment of sensation\n* 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\n* Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy\n* Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)",true,"ALL","18 Years",{"count":85,"type":86},400,"ESTIMATED","OBSERVATIONAL","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.",[90,91,92,93,94,95,96,97,98],"Sensation Disorders","Sensation, Phantom","Pain, Postoperative","Pain, Chronic","Numbness","Sensory Disorder","Sensory Defect","Phantom Pain","Phantom Sensation",[100,101,102,103,104,105,106,107,108,109,110],"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","2025-08-26",{"date":113,"type":114},"2025-08-27","ACTUAL",{"date":116,"type":114},"2022-02-09",{"date":118,"type":86},"2033-03",{"name":5,"class":6},2]