[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611217":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":33,"locations":32,"responsibleParty":39,"collaborators":43,"id":47,"slug":32,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":32,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":32,"enrollmentInfo":55,"targetDuration":32,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":32,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":32},{"fullName":5,"class":6},"Ankara City Hospital Bilkent","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"SV-2-40 or SV-3-60","EXPERIMENTAL","Patients with a Visual Analogue Scale (VAS) score of 80 mm or higher will receive a single injection of SV-3-60 (Sterile Sodium Hyaluronate Gel-3 mL Prefilled Syringe (2.0%)), whereas those with a score below 80 mm will receive a single injection of SV-2-40 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (2.0%) )",[13],"Device: Sensovisc®",{"label":15,"type":10,"description":16,"interventionNames":17},"SV-2-32","For the patients who will be injected with SV-2-32 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (1.6%)), a second injection will be performed 1 week after the first injection.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"SV-2-20","3 intra-articular injections of SV-2-20 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (1.0%)) administered 1 weeks apart. For the subject in the SV-2-20 group, a second and third injection will be performed one week and two weeks after the first injection.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Sensovisc®","Injectable Sterile Sodium Hyaluronate Gel",[19,15,9],[29,30,31],"Hyaluronic Acid Gel","Intra-articular injection","Sodium Hyaluronate",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Hayriye Şimşek Özgüner","CONTACT","+90 312 552 60 00","dr.hayriye.simsek@gmail.com",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Emre Adıgüzel","Prof. MD",[44],{"name":45,"class":46},"İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi","UNKNOWN","100611217",false,"NCT07237711","Clinical Investigation of Sensovisc","Clinical Investigation of Sensovisc Sterile Sodium Hyaluronate Gel in the Knee Joint","Inclusion Criteria:\n\n* Patients who have unilateral and\u002For bilateral knee pain for more than 3 months and meet the diagnosis of osteoarthritis according to ACR criteria\n* Diagnosis of Stage II or III knee OA according to the Kellgren and Lawrence (K\\&L) classification, determined by x-rays taken in the last 12 months\n* 40 mm above the pain level determined by VAS during rest for at least 15 days in the month before starting the study (for paracetamol and oral nonsteroidal anti-inflammatory drugs (NSAIDs), taking into account the half-life of the drug)\n* Having a Body Mass Index (BMI) ≤ 40 kg\u002Fm²,\n* Having the mental ability to express pain scores\n* Signing the informed consent form indicating consent to participate in the study\n\nExclusion Criteria:\n\n* Radiological K\\&L stage I and IV\n* Acute inflammatory osteoarthritis attack (KOFUS ≥7)\n* Septic arthritis\n* Secondary OA \\[Synovial chondromatosis or pigmented villonodular synovitis of the knee, Joint diseases (joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis), Inflammatory diseases (rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis)\\]\n* Ipsilateral cruciate or collateral ligament injury in the last 3 months,\n* Corticosteroid injection into the target knee within the last 1 month before the first injection\n* Hyaluronat injection into the target knee within the last 6 months before the first injection\n* Arthroscopy or surgery on the target knee within the last 6 months before the first injection","ALL","18 Years",{"count":56,"type":57},75,"ESTIMATED","INTERVENTIONAL",[60],"NA","This clinical investigation aims to investigate the safety and performance of Sensovisc.\n\nSensovisc is used to reduce osteoarthritis (OA) related pain in the joints by supporting synovial fluid by intra-articular injection and allowing the synovial fluid to restore its viscoelastic properties. It increases the joint mobility by reducing or eliminating the pain.\n\nThis Clinical Investigation was designed as a cross-sectional, interventional, and prospective study.",[63],"Osteo Arthritis of the Knee",[65,66,67,68,69],"viscosupplementation","knee osteoarthritis","hyaluronic acid","dosing","Sensovisc","NOT_YET_RECRUITING","2025-11-18",{"date":73,"type":74},"2025-11-20","ACTUAL",{"date":76,"type":57},"2025-11-25",{"date":78,"type":57},"2026-11-25",{"name":5,"class":6}]