[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fenestration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fenestration":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100633875","occlutech-afr-fontan-study-100633875",false,"NCT07532369","Occlutech AFR Fontan Study","Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population","Inclusion Criteria:\n\n* The patient has been treated with an AFR device (attempted or successful) for failing Fontan through the Expanded Access Program of the Food and Drug Administration (FDA).\n* The candidate\u002Fcandidate's legal guardian has been informed of the nature of the study, agrees to its provisions and has provided written informed consent unless the site's IRB provided a waiver of consent.\n\nExclusion Criteria:\n\n* If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included","ALL",{"count":18,"type":19},25,"ESTIMATED","OBSERVATIONAL","The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation. This study will consist of a case series of congenital patients with Fontan failure who have been treated with an Occlutech AFR under the FDA's Expanded Access process.\n\nThe scope of this study is to gain clinical experience on the Occlutech AFR in Fontan failure patients. Cases in this study will be evaluated to evaluate the safety and effectiveness of the device.\n\nThe objective of this study is to evaluate the Occlutech AFR with respect to device safety and shunt patency at 1 year. Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.",[23,24,25,26],"Failure of Fontan Type Circulation","Fenestration","Univentricular Heart","Congenital Anomaly","NOT_YET_RECRUITING","2026-04-08",{"date":30,"type":31},"2026-04-15","ACTUAL",{"date":33,"type":19},"2026-05-01",{"date":35,"type":19},"2026-09",{"name":37,"class":38},"Occlutech International AB","INDUSTRY",7,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100622587","the-importance-of-adding-fenestration-to-ultrasound-guided-bakers-cyst-aspiration-100622587","NCT07385560","\"The Importance of Adding Fenestration to Ultrasound-Guided Baker's Cyst Aspiration\"","Inclusion Criteria:\n\n* Adults aged 40 to 75 years\n* Diagnosis of knee osteoarthritis according to the 2010 American College of Rheumatology (ACR) criteria\n* Presence of a symptomatic Baker's cyst confirmed by ultrasonography\n* Ability to understand study procedures and provide written informed consent\n* Sufficient intellectual and social capacity to comply with study visits and follow-up requirements\n\nExclusion Criteria:\n\n* Presence of inflammatory arthritis, septic arthritis, crystal arthropathy, or secondary causes of knee osteoarthritis\n* Kellgren-Lawrence grade 4 knee osteoarthritis\n* Active systemic infection\n* History of malignancy\n* Intra-articular knee injection within the past 3 months\n* Knee trauma within the past 3 months\n* History of knee surgery\n* Contraindications to aspiration or corticosteroid injection (e.g., local infection, bleeding disorders, uncontrolled diabetes mellitus)\n* Requirement to continue medications for inflammatory arthritis\n* Diagnosed psychiatric disorder that may impair study participation\n* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within the past 1 week\n* Physical therapy applied to the knee region within the past 1 month","40 Years","75 Years",{"count":49,"type":19},44,"INTERVENTIONAL",[52],"NA","This study aims to evaluate whether adding a fenestration procedure to standard ultrasound-guided aspiration and corticosteroid-lidocaine injection provides additional clinical benefits for patients with symptomatic Baker's cyst associated with knee osteoarthritis. Baker's cyst is a fluid-filled swelling located behind the knee that may cause pain, stiffness, swelling, and limited mobility. Although aspiration with medication injection is commonly used to relieve symptoms, recurrence of the cyst is frequent.\n\nFenestration is a minimally invasive technique in which small controlled openings are created in the cyst wall under ultrasound guidance to improve internal drainage and potentially reduce recurrence. In this prospective, randomized, double-blind, controlled study, participants will be assigned to one of two groups:\n\n1. aspiration with corticosteroid and lidocaine injection, or\n2. aspiration with corticosteroid and lidocaine injection plus fenestration.\n\nPain, functional scores, cyst measurements, and recurrence will be assessed at follow-up visits at 2 weeks, 1 month, and 3 months. The purpose of this study is to determine whether the addition of fenestration results in better symptom improvement and lower rates of recurrence compared with standard aspiration alone.",[55,24,56,57,58,59],"Baker Cyst","Musculoskeletal Ultrasound","Steroid Injection","OMERACT","Knee Osteoarthritis",[61,62,63,64,65,24,58,66,67,68,69],"Baker's cyst","Knee osteoarthritis","Ultrasound-guided aspiration","Steroid injection","Lidocaine","WOMAC","Musculoskeletal ultrasound","Cyst recurrence","KOOS","2026-01-29",{"date":72,"type":31},"2026-02-04",{"date":74,"type":19},"2026-02-15",{"date":76,"type":19},"2026-05-30",{"name":78,"class":79},"Istanbul University - Cerrahpasa","OTHER",1]