[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"benign-breast-condition\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:benign-breast-condition":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100521762","the-role-of-amnion-membrane-allografts-in-nipple-preservation-100521762",false,"NCT06073808","The Role of Amnion Membrane Allografts in Nipple Preservation","The Role of Amnion Membrane Allografts in Nipple Preservation After Nipple Sparing Mastectomy: A Double-Blinded Randomized Controlled Trial","AmnioFix","Inclusion Criteria:\n\n* Biologically female with documented diagnosis of gender dysphoria, desire to undergo gender affirming surgery (female-to-male) NSM, and age 15 years of age or older.\n* Biological female, age 18 to 75 years old, who desire to undergo bilateral prophylactic NSM for nonmalignant breast conditions or to reduce the risk of breast cancer.\n\nExclusion Criteria:\n\n* Current steroid use\n* Known connective tissue disorder\n* Known neuropathy\n* Known history of breast cancer\n* History of breast radiotherapy\n* Pregnant or nursing",true,"ALL","15 Years","75 Years",{"count":22,"type":23},30,"ESTIMATED","INTERVENTIONAL",[26],"NA","The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion\u002Fchorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially available tissue membranes with biocompatible extracellular matrix and growth factors that have been shown to improve wound healing in patients with chronic and lower extremity wounds. To date, no study has evaluated the impact of dHACMs on NAC preservation following NSM. Investigators hypothesize that subareolar surgical implantation of dHACM allografts at time of NSM will reduce NAC necrosis and improve viability.",[29,30,31,32,33],"Mastectomy","Gender Affirmation Surgery","Nipple Sparing Mastectomy","Prophylactic Mastectomy","Benign Breast Condition",[35,36],"nipple sparing mastectomy","gender affirming surgery","NOT_YET_RECRUITING","2026-04-24",{"date":40,"type":41},"2026-04-30","ACTUAL",{"date":43,"type":23},"2026-06-01",{"date":45,"type":23},"2026-09",{"name":47,"class":48},"Stanford University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":74,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":49},"100631831","atusa-ultrasound-diagnostic-imaging-for-breast-lesions-evaluation-audible-100631831","NCT07505797","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.","AUDIBLE","Inclusion Criteria:\n\n1. Provide written informed consent through a signed and dated consent form.\n2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.\n3. Be female, aged 18 to 94 years (inclusive).\n4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.\n\nExclusion Criteria:\n\n1. Active skin lesions (open wounds or unhealed sores) on either breast.\n2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.\n3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.\n4. Previous bilateral mastectomy.\n5. Physical inability to maintain a supine position for 30 minutes.\n6. Breast anatomy incompatible with ATUSA device specifications.\n7. Recent (within 12 months) breast surgery or cancer treatment.\n8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.\n9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.","FEMALE","18 Years","94 Years",{"count":62,"type":23},800,"7 Days","OBSERVATIONAL","AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes.\n\nThe study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden.\n\nThis study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.",[67,33,68,69,70,71,72,73],"Breast Cancer","Breast Fibroadenoma","Breast Neoplasms","Breast Disease","Breast Cancer Female","Breast Pain","Breast Cancer Invasive",[75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"breast cancer","breast lesions","dense breasts","invasive breast carcinoma","benign breast disease","ATUSA","Automated Breast Utrasound","ABUS","Ultrasound breast imaging","multimodality imaging","ultrasound","registry","image quality","AI","AI Model Training","medical device","iSono Health","RECRUITING","2026-03-26",{"date":95,"type":41},"2026-04-01",{"date":97,"type":41},"2025-12-16",{"date":99,"type":23},"2026-12-31",{"name":101,"class":102},"iSono Health, Inc.","INDUSTRY"]