[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514148":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":61,"collaborators":24,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":24,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":24,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":24,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Mesh-based crural reinforcement","Patient will receive Ovitex mesh to reinforce the crural repair",[12],"Device: OviTex Mesh",{"label":14,"type":6,"description":15,"interventionNames":16},"Pledgeted suture-based crural reinforcement","Patient will receive pledgeted sutures to reinforce the crural repair",[17],"Other: Pledgeted sutures",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","OviTex Mesh","Patient will receive Ovitex Mesh (TELA Bio)",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Pledgeted sutures","Patient will receive pledgeted sutures",[14],[30],{"name":31,"affiliation":5,"role":32},"David M Krpata, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","216 445-3441","krpatad@ccf.org",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"William C Bennett, MD","216 313-8971","bennetw2@ccf.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cleveland Clinic Center for Abdominal Core Health","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.69541,41.4995,{"lat":55,"lon":54},[58],{"name":59,"role":35,"phone":36,"phoneExt":24,"email":60},"Michael J Rosen, MD","rosenm@ccf.org",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","David Krpata","Professor of Surgery, CCF Lerner College of Medicine","100514148","mesh-vs-pledgets-for-repair-of-paraesophageal-hernia-100514148",false,"NCT05974722","Mesh Vs Pledgets for Repair of Paraesophageal Hernia","A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence","Inclusion Criteria:\n\n* 18 years of age or older\n* Willing and able to provide informed consent\n* Willing and able to participate in long-term follow up including study visits and surveys\n* Type II, III, or IV hiatal hernia \\> 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively\n\nExclusion Criteria:\n\n* Pregnancy\n* BMI \\>45\n* Allergy to any components of mesh\n* Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to reduce stomach volume (sleeve gastrectomy, roux-en-y gastric bypass, duodenal switch, single-anastomosis gastric bypass, and partial or total gastrectomy)\n* Patients who have undergone previous hiatal hernia repair","ALL","18 Years",{"count":75,"type":76},164,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are:\n\n* Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair.\n* Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms",[82,83],"Paraesophageal Hernia","GERD","2025-10-02",{"date":86,"type":87},"2025-10-07","ACTUAL",{"date":89,"type":87},"2023-09-11",{"date":91,"type":76},"2028-12",{"name":63,"class":6},1]