[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Koya Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100548229","clinical-study-to-evaluate-the-effectiveness-and-health-economics-of-a-novel-portable-non-pneumatic-active-compression-device-npcd-for-lymphedemaphlebolymphedema-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":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"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",[28,29,30],"Phlebolymphedema","Lymphedema","Chronic Venous Insufficiency","RECRUITING","2026-04-28",{"date":34,"type":35},"2026-05-04","ACTUAL",{"date":37,"type":35},"2024-05-13",{"date":39,"type":22},"2027-12-31",{"name":41,"class":42},"Koya Medical, Inc.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"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","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",{"count":52,"type":22},20,[25],"To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery",[29,56,57],"Lymphedema, Breast Cancer","Lymphedema Arm","2021-05-18",{"date":60,"type":35},"2021-05-20",{"date":62,"type":22},"2021-06-01",{"date":64,"type":22},"2021-12-31",{"name":41,"class":42},""]