[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"phlebolymphedema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:phlebolymphedema":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29],"Phlebolymphedema","Lymphedema","Chronic Venous Insufficiency","RECRUITING","2026-04-28",{"date":33,"type":34},"2026-05-04","ACTUAL",{"date":36,"type":34},"2024-05-13",{"date":38,"type":21},"2027-12-31",{"name":40,"class":41},"Koya Medical, Inc.","INDUSTRY",""]