[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430737":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":25,"responsibleParty":42,"collaborators":18,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":18,"enrollmentInfo":53,"targetDuration":18,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":18,"overallStatus":27,"whyStopped":18,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Koya Medical, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery","EXPERIMENTAL",[12],"Device: Dayspring Active Wearable Compression System",[14],{"type":15,"name":16,"description":16,"armGroupLabels":17,"otherNames":18},"DEVICE","Dayspring Active Wearable Compression System",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Dung Nguyen, MD, PharmD","CONTACT","4158510337","info@koyamedical.com",[26],{"facility":21,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Palo Alto","California","94304","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-122.14302,37.44188,{"lat":37,"lon":36},[40],{"name":21,"role":22,"phone":41,"phoneExt":18,"email":24},"415-851-0337",{"type":43,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100430737","a-non-randomized-open-label-study-to-evaluate-the-safety-and-effectiveness-of-the-dayspring-technology-for-patients-with-breast-cancer-related-lymphedema-bcrl-after-lymphatic-surgery-100430737",false,"NCT04888975","A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery","TIGRIS","Inclusion Criteria:\n\n* Males and females ≥ 18 years of age\n* Willing to sign the informed consent and deemed capable of following the study protocol\n* Subjects must have a diagnosis of upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen\n* Subjects must have a difference in volume greater than 3% between the limbs.\n\nExclusion Criteria:\n\n* Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy\n* Inability or unwillingness to participate in all aspects of study protocol and\u002For inability to provide informed consent\n* Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)\n* Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer\n* Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device\n* Diagnosis of lipedema\n* Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study\n* Diagnosis of acute thrombophlebitis (in last 2 months)\n* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months\n* Diagnosis of pulmonary edema\n* Diagnosis of congestive heart failure (uncontrolled)\n* Diagnosis of chronic kidney disease\n* Diagnosis of epilepsy\n* Patients with poorly controlled asthma\n* Women who are pregnant, planning a pregnancy or nursing at study entry\n* Participation in any clinical trial of an investigational substance or device during the past 30 days\n* Bilateral limb edema","ALL","18 Years",{"count":54,"type":55},20,"ESTIMATED","INTERVENTIONAL",[58],"NA","To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery",[61,62,63],"Lymphedema","Lymphedema, Breast Cancer","Lymphedema Arm","2021-05-18",{"date":66,"type":67},"2021-05-20","ACTUAL",{"date":69,"type":55},"2021-06-01",{"date":71,"type":55},"2021-12-31",{"name":5,"class":6},1]