[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Progenerative Medical, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100536021","phase-1-regenn-therapy-system-safety-study-100536021",false,"NCT06259409","Regenn® Therapy System Safety Study","A Randomized Clinical Study Evaluating the Safety of Regenn® Negative Pressure Therapy System in Orthopaedic Surgical Wound Management","Inclusion Criteria (must meet ALL):\n\n* Subject has provided written informed consent on a form reviewed and approved by the Institutional Review Board for the clinical site.\n* The subject is 18 - 80 years old.\n* The subject has Spondylolisthesis of Meyerding Grade II or less, or has Degenerative Disc Disease (DDD) accompanied by back pain with or without leg pain at a level between L1 and S1 confirmed by history and radiographic assessment. DDD is determined to be present if one or more of the following are noted:\n\n  * Instability (defined as angulation ≥ 5 degrees and\u002For translation ≥ 3mm on flexion\u002Fextension radiographs;\n  * Osteophyte formation of facet joints or vertebral endplates;\n  * Decreased disc height, on average by \\>2mm, but dependent upon the spinal level;\n  * Scarring \u002F thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;\n  * Herniated nucleus pulposus;\n  * Facet joint degeneration \u002F changes; and\u002For\n  * Vacuum phenomenon.\n* Female subjects of childbearing potential must not be pregnant or nursing and must agree to use of contraception for the study duration. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test and birth control.\n* The subject is willing and able to comply with the protocol mandated follow-up visits and testing regimen.\n\nExclusion Criteria (candidates meeting ANY of the following at the time of the study procedure are NOT eligible):\n\n* Subject is unable or unwilling to provide informed consent or is unable to conform to the study protocol follow-up procedures and visits.\n* Subject has a contraindication (including allergic reaction) to antiplatelet\u002Fanticoagulant medications, nickel, titanium, bone allograft, or blood transfusion that is not amenable to pretreatment with steroids or\u002Fand antihistamines.\n* Subject has a history of bleeding diatheses or coagulopathy.\n* Subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or any autoimmune diseases.\n* Subject is receiving dialysis or immunosuppressive therapy.\n* Subject suffered a hemorrhagic stroke \\\u003C 6 months prior to the study procedure.\n* Subject is undergoing spinal surgery for vertebral fracture, trauma, or scoliosis.\n* Subject has any form of active malignancy.\n* Subject is an intravenous drug user and\u002For alcoholic.\n* Subject is diagnosed with septicemia at the time of the study procedure.\n* Subject is a smoker.\n* Subject has Type I diabetes.\n* Subject has overt, uncontrolled Type II diabetes.\n* Subject has a condition requiring postoperative medications that would be expected to interfere with fusion (e.g., steroids), or has received drugs that interfere with bone metabolism within 2 weeks of the surgery.\n* Subject is suffering from gross obesity, defined as \\> 40% IBW.\n* Subject exhibits Waddell signs of Inorganic Behavior ≥ 3.\n* Subject has had a previous, anterior spinal fusion, interbody spinal fusion, or posterior spinal instrumentation at the involved level.\n* Subject has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.\n* Subject has a systemic disease of connective tissue such as Rheumatoid Arthritis, or Ankylosing Spondylitis.\n* Subject is a prisoner.\n* Subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).",true,"ALL","18 Years","80 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are:\n\n* The device-related serious adverse event rate.\n* Patient post-operative pain as assessed using a validated pain measurement scoring system.\n* The number and type of adverse events.\n* The rate of delayed seroma formation.\n\nParticipants will\n\n* Be screened for their suitability to participate in the investigational study using questions about their health, medical history, and current medications.\n* Undergo a physical exam, an assessment of patient vital signs and routine blood analyses.\n* Complete an Informed Consent Form if selected to participate in the investigational study.\n* Be randomly assigned to the different study arms.\n* Not change the operation of their respective device or to disturb components of their device.\n* Notify their surgeon or designated healthcare provider should they have any questions or encounter any issues with their device.\n* Attend two post-operative visits at approximately one month and three months.",[28],"Surgical Wound","RECRUITING","2025-09-08",{"date":32,"type":33},"2025-09-15","ACTUAL",{"date":35,"type":33},"2024-10-09",{"date":37,"type":22},"2026-06",{"name":39,"class":40},"Progenerative Medical, Inc","INDUSTRY",""]