[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592514":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The Fourth Affiliated Hospital of China Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental",null,"Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation.",[13],"Device: novel fluorescent localization marker needle",{"label":15,"type":10,"description":16,"interventionNames":17},"Control","Patients received breast ductal excision surgery utilizing conventional localization methods. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation.",[18],"Device: conventional localization marker needle",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","novel fluorescent localization marker needle","novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"conventional localization marker needle","conventional localization marker needle, without any coating",[15],[30],{"name":31,"affiliation":5,"role":32},"Jian Wen, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":10,"email":37},"CONTACT","+86 18900912982","wenjian@cmu.edu.cn",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Shenyang","Liaoning","110032","China","CN",{"type":47,"coordinates":48},"Point",[49,50],123.43278,41.79222,{"lat":50,"lon":49},[53,54],{"name":31,"role":35,"phone":36,"phoneExt":10,"email":37},{"name":31,"role":32,"phone":10,"phoneExt":10,"email":10},{"type":32,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"JIAN WEN","Deputy Director of the Fifth General Surgery Department","100592514","a-novel-fluorescent-ductal-needle-for-localization-and-sampling-of-high-risk-breast-micro-lesions-100592514",false,"NCT06994416","A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions","A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study","Inclusion Criteria:\n\n1. Female patients aged 18-75 years.\n2. Patients who have been diagnosed intraductal breast lesion by ductoscopy.\n3. Patients who have undergone ductal excision.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Patients who have known allergy to quantum-dot materials or localization needle components.\n3. Patients with active hepatitis B or C infection with detectable viral load.\n4. Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).\n5. Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).\n6. Patients with incomplete clinical data.\n7. Patients who concurrent participation in another interventional clinical trial.","FEMALE","18 Years","75 Years",{"count":69,"type":70},300,"ESTIMATED","OBSERVATIONAL","This retrospective cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization techniques for breast duct lesions. The primary goal is to evaluate the clinical effectiveness of this innovative fluorescent localization needle in facilitating accurate pathological diagnoses of micro lesions situated within breast ducts.",[74,75],"Mammary Tumor","Nipple Discharge",[77,78,79,80,81],"micro lesions","breast duct","fluorescent ductal needle","localization needle","controllable detachment","2026-06-10",{"date":84,"type":85},"2026-06-11","ACTUAL",{"date":87,"type":85},"2025-06-01",{"date":89,"type":70},"2026-05-31",{"name":5,"class":6},1]