[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548229":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":40,"collaborators":20,"id":42,"slug":20,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":20,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Koya Medical, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dayspring, Non-Pneumatic Active Compression Device (NPCD)","EXPERIMENTAL","The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.",[13],"Device: Dayspring",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Dayspring","NPCD",[9],null,[22],{"facility":23,"status":24,"city":25,"state":25,"zip":26,"country":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Glenn Jacobowitz","RECRUITING","New York","10016","United States",{"type":29,"coordinates":30},"Point",[31,32],-74.00597,40.71427,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":20,"email":39},"Glenn Jacobowitz, MD","CONTACT","415-851-0337","clinical@koyamedical.com",{"type":41,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100548229",false,"NCT06418282","Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema\u002FPhlebolymphedema","An Open-label, Multi-center, Prospective VA Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema\u002FPhlebolymphedema","GRANDE","Inclusion Criteria:\n\n* Males and females ≥ 18 years of age\n* Capable and willing to sign the informed consent and deemed capable of following the study protocol\n* Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema\u002Fphlebolymphedema as a consequence of chronic venous insufficiency\n* Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial\u002Fdeep reflux\n\nExclusion Criteria:\n\n* Inability or unwillingness to participate in all aspects of study protocol and\u002For inability to provide informed consent\n* Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy\n* Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device\n* Non-ambulatory individuals\n* Female: BMI \\> 34 (5'4\", 200 lbs.)\n* Male: BMI \\> 34 (5'9\", 230 lbs.)\n* (Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)\n* Diagnosis of lipedema\n* Diagnosis of active or recurrent cancer (\\\u003C 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)\n* Diagnosis of acute infection (in the last four weeks)\n* Diagnosis of active\u002Fopen wound\u002Fulcer\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\u002Funcompensated)\n* Diagnosis of chronic kidney disease with acute renal failure\n* Diagnosis of epilepsy\n* Subjects with poorly controlled asthma\n* Any condition where increased venous and lymphatic return is undesirable\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","ALL","18 Years","100 Years",{"count":53,"type":54},100,"ESTIMATED","INTERVENTIONAL",[57],"NA","An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema\u002Fphlebolymphedema",[60,61,62],"Phlebolymphedema","Lymphedema","Chronic Venous Insufficiency","2026-04-28",{"date":65,"type":66},"2026-05-04","ACTUAL",{"date":68,"type":66},"2024-05-13",{"date":70,"type":54},"2027-12-31",{"name":5,"class":6},1]