[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07537153":3,"trial-entities:NCT07537153":121,"trial-summary:NCT07537153":125},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":56,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":91,"locations":94,"central_contacts":109,"overall_officials":116,"references":119,"see_also_links":120},"NCT07537153","STU00223591","Genicular Artery Embolization for Knee Osteoarthritis","Genicular Artery Embolization for Patients With Mild-To-Moderate Knee Osteoarthritis","RECRUITING","2031-04-10","2026-07","2026-07-14","2026-07-10","Northwestern University","OTHER",true,"Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA.\n\nResearch participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits.\n\nAt the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue.\n\nThe follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.",null,[19,20],"Osteoarthritis","Knee Osteoarthritis",[19,20,22,23,24,25,26],"Genicular Artery Embolization","GAE","Embosphere Microspheres","GAE Knee","GAE Embosphere Microspheres","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},15,"ESTIMATED",[35],{"type":36,"name":24,"description":37,"armGroupLabels":38},"DEVICE","Genicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee. Tiny particles are then injected through the catheter into these arteries, reducing the blood supply. These small particles are considered a medical device called Embosphere Microspheres. These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations. The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA.",[39],"GAE Procedure",[41,45,49,53],{"measure":42,"description":43,"timeFrame":44},"Patient safety endpoints","Primary safety endpoints include:\n\n1\\. Incidence and severity of adverse events (AEs). These include:\n\n1. Non-target embolization (e.g., distal leg)\n2. All transient intra- and post-procedure events (e.g., skin changes)\n3. Death","Screening\u002Fbaseline, 1, 3, and 6 months",{"measure":46,"description":47,"timeFrame":48},"Objective clinical endpoints - Cone beam computed tomography","Change in enhancement on cone beam computed tomography (CT)","Immediately pre-and post-embolization",{"measure":50,"description":51,"timeFrame":52},"Objective clinical endpoints - VAS","Change in Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain). Consequently, higher scores indicate a worse outcome (more pain\u002Fseverity), while lower scores indicate a better outcome","Screening\u002Fbaseline, 1, 3, 6, 12, 24 and 36 months",{"measure":54,"description":55,"timeFrame":52},"Objective clinical endpoints - WOMAC","Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).",[57,61],{"measure":58,"description":59,"timeFrame":60},"Preliminary Effectiveness - WOMAC","Secondary endpoint will be evaluated based on existing validated pain scoring systems. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis will be utilized. Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).","Screening\u002Fbaseline, 1, 3, 6, and 12 months",{"measure":62,"description":63,"timeFrame":60},"Preliminary Effectiveness - VAS","Secondary endpoint will be evaluated based on existing validated pain scoring systems. The Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain) will be utilized. Consequently, higher scores indicate a worse outcome (more pain\u002Fseverity), while lower scores indicate a better outcome.","ALL","40 Years","80 Years",false,{"inclusion":69,"exclusion":77,"raw_text":90},[70,71,72,73,74,75,76],"Age 40-80 years","Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3","Self-reported pain of at least 5\u002F10 VAS questionnaire","Failure of conservative therapy, such as pain medications, for at least 3 months","Patient must understand and sign the informed consent","Patient can comply with the proposed follow-up schedule","Patient can follow the post-operative management",[78,79,80,81,82,83,84,85,86,87,88,89],"History of rheumatoid arthritis","Renal insufficiency precluding angiography (GFR \\\u003C 50 mL\u002Fmin)","Irreversible coagulopathy","Previous knee arthroplasty on the intended knee","Existing knee joint infection","Kellgren-Lawrence grade 1 or 4","Severe atherosclerosis as manifest by claudication and\u002For diminished peripheral pulses","Life expectancy \\\u003C 6 months","Infectious arthritis","Allergy to iodinated contrast resulting in anaphylaxis","Pregnant or interested in becoming pregnant three months from the date of the GAE procedure","Involved in litigation or worker's compensation claims","Inclusion Criteria:\n\n* Age 40-80 years\n* Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3\n* Self-reported pain of at least 5\u002F10 VAS questionnaire\n* Failure of conservative therapy, such as pain medications, for at least 3 months\n* Patient must understand and sign the informed consent\n* Patient can comply with the proposed follow-up schedule\n* Patient can follow the post-operative management\n\nExclusion Criteria:\n\n* History of rheumatoid arthritis\n* Renal insufficiency precluding angiography (GFR \\\u003C 50 mL\u002Fmin)\n* Irreversible coagulopathy\n* Previous knee arthroplasty on the intended knee\n* Existing knee joint infection\n* Kellgren-Lawrence grade 1 or 4\n* Severe atherosclerosis as manifest by claudication and\u002For diminished peripheral pulses\n* Life expectancy \\\u003C 6 months\n* Infectious arthritis\n* Allergy to iodinated contrast resulting in anaphylaxis\n* Pregnant or interested in becoming pregnant three months from the date of the GAE procedure\n* Involved in litigation or worker's compensation claims",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":13,"status":8,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":106},"Chicago","Illinois","60611","United States",[101],{"name":102,"role":103,"phone":104,"email":105},"Robert Lewandowski, MD","CONTACT","312-695-9121","r-lewandowski@northwestern.edu",{"lat":107,"lon":108},41.85003,-87.65005,[110,112],{"name":102,"role":103,"phone":104,"email":111},"r-lewandowki@northwestern.edu",{"name":113,"role":103,"phone":114,"email":115},"Kristie Kennedy, MA","312-695-4023","kristie.kennedy@northwestern.edu",[117],{"name":102,"affiliation":13,"role":118},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":122,"biomarkers":124},[123],"Osteoarthritis of knee",[],{"nct_id":4,"found":15,"summary":126,"prompt_version":135},{"design":127,"status":128,"heading":6,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This is an interventional study with a planned enrollment of 15 participants. The study does not specify if it is randomized or blinded.","completed","This study is looking at a procedure called Genicular Artery Embolization (GAE) using Embosphere Microspheres to treat knee pain caused by mild-to-moderate osteoarthritis (OA). OA happens when the protective cartilage in your knee wears down. GAE involves guiding a small tube (catheter) to the arteries in your knee to help with pain. The study wants to see if GAE is safe and effective. You may be able to join if you are 40-80 years old, have mild-to-moderate knee OA, experience at least 5\u002F10 pain, and haven't found relief with other treatments for at least 3 months. The study will measure your safety and pain levels over time.","Your safety will be checked at 1, 3, and 6 months. Your pain levels will be checked at 1, 3, 6, 12, 24, and 36 months after the procedure.",107,"You would be in this study for about 3 years, including a screening visit, the GAE procedure, and six follow-up visits.","Not stated in the trial record.",[24],"v2"]