[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-disease":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,66,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100631831","atusa-ultrasound-diagnostic-imaging-for-breast-lesions-evaluation-audible-100631831",false,"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":21,"type":22},800,"ESTIMATED","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.",[27,28,29,30,31,32,33,34],"Breast Cancer","Benign Breast Condition","Breast Fibroadenoma","Breast Neoplasms","Breast Disease","Breast Cancer Female","Breast Pain","Breast Cancer Invasive",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"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":56,"type":57},"2026-04-01","ACTUAL",{"date":59,"type":57},"2025-12-16",{"date":61,"type":22},"2026-12-31",{"name":63,"class":64},"iSono Health, Inc.","INDUSTRY",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":74,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":65},"100555073","postoperative-analgesia-intervention-with-non-opioid-alternatives-pain-alt-trial---breast-surgery-100555073","NCT06507345","Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery","Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery: A Protocol for a Randomized Controlled Trial (PAIN-Alt Trial)","PAIN-Alt","Inclusion Criteria:\n\n* Undergoing mastectomy (i.e., total, modified radical, radical, or skin\u002Fnipple sparing) or lumpectomy (i.e., excisional biopsy, partial or segmental mastectomy, oncoplastic breast-conserving surgery) for malignant (cancer) and non-malignant diseases (i.e., ductal carcinoma in situ)\n* Planned discharge on the day of the operation.\n\nExclusion Criteria:\n\n* Immediate breast reconstruction, i.e., implant, tissue-expander, or autologous\u002Fflap-based (often leads to higher levels of pain and analgesia requirements)\n* Contraindications to the drugs used in the trial in accordance with Health Canada Monographs (i.e., opioid use disorder, pregnancy, breastfeeding, heart failure, allergy\u002Fhypersensitivity, peptic ulcer, bleeding disorders, renal or liver impairment)\n* Taking opioids preoperatively\n* Cognitive impairment precluding patient-reported outcome assessment\n* Need for postoperative hospitalization decided before randomization (i.e., same-day discharge cancelled for medical \\[e.g., intra-operative complications\\] or non-medical reasons \\[e.g., lack of support at home\\]).","ALL",{"count":76,"type":22},540,"INTERVENTIONAL",[79],"NA","North America is experiencing a crisis of opioid use and abuse, partially caused by excessive prescribing by doctors. People often receive their first opioid prescription for pain treatment after outpatient breast surgery (i.e., surgery to remove all or parts of the breast(s), where patients leave the hospital the same day). Many patients misuse these drugs and become addicted. Additionally, many of the opioid pills prescribed to patients are left unused and may be misused by family members, friends, or other community members. To prevent this problem, surgeons can avoid prescribing opioids by prioritizing opioid-free analgesia (i.e., pain treatment using only non-opioid interventions). Prescribing only non-opioid pain medications after surgery is very common in many countries outside of North America; however, few studies have assessed whether opioid-free analgesia is as effective as opioid analgesia after breast surgery. Therefore, the main question driving this study is: For patients who undergo outpatient breast surgery, is pain treatment without opioids as good as pain treatment with opioids?\n\nThe proposed trial will compare two groups of patients: one group will receive opioids to treat pain after surgery, while the other group will receive only non-opioid medications. The impact of these different medication strategies will be measured on pain intensity, pain interference with daily activities, medication side effects, and other outcomes. An expert team of scientists, surgeons, pain specialists, nurses, and patients has been assembled to maximize the success of this study. The results will provide important information to guide surgeons' decisions to prescribe (or not to prescribe) opioids. If opioid-free analgesia is found to be effective, doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids.",[82,83,84,85,31],"Post Operative Pain","Opioid Analgesic Adverse Reaction","Surgery","Postoperative Pain",[84,87,88,89,90,91],"Postoperative analgesia","Breast surgery","Opioids","Postoperative pain","Postoperative care","2025-01-10",{"date":94,"type":57},"2025-01-13",{"date":96,"type":57},"2024-11-26",{"date":98,"type":22},"2026-02-28",{"name":100,"class":101},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":65},"100568250","endoscopic-anatomy-of-the-breast-fascia-system-100568250","NCT06678776","Endoscopic Anatomy of the Breast Fascia System","Endoscopic Anatomy of the Breast Fascia System: A Reverse Development Theory","Inclusion Criteria:\n\n* Breast cancer patients who need mastectomy and patients who need breast reduction during the study period.\n\nExclusion Criteria:\n\n* breast conserving surgery",{"count":110,"type":22},184,"This study will focus on two key theories: the development theory of the breast fascia system and the reverse development theory. The research findings indicate that breast development generally follows a growth pattern from anterior to posterior, and from central to peripheral regions. However, an intriguing phenomenon contradicting this developmental process was discovered through endoscopic mastectomy, which has not been previously discussed. Based on the aforementioned theoretical analysis, this study includes patients who underwent endoscopic and reduction mammaplasty in the Department of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University. The investigators proposed the following research framework: firstly, comprehensively understanding the structure of the breast fascia and the sequence of breast development through endoscope and existing research; secondly, exploring the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty; lastly, proposing a reverse development theory for breast fascia based on these theories in order to provide standardized and procedural guidance for breast surgeons.",[31,113],"Anatomy","2024-11-06",{"date":116,"type":57},"2024-11-07",{"date":118,"type":57},"2019-06-01",{"date":120,"type":22},"2024-12-30",{"name":122,"class":101},"Haiyan Li"]