[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530958":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":57,"collaborators":19,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":19,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Foregut Research Foundation","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair","This is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators.",[12],"Device: Ovitex LPR",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Ovitex LPR","Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Kate Freeman, MSN","STUDY_DIRECTOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","3037887700","kate@iersurgery.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Institute of Esophageal and Reflux Surgery","RECRUITING","Lone Tree","Colorado","80124","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-104.8863,39.55171,{"lat":42,"lon":41},[45,47,51,54],{"name":22,"role":26,"phone":46,"phoneExt":19,"email":28},"303-788-7700",{"name":48,"role":26,"phone":46,"phoneExt":49,"email":50},"Rachel Heidrick, BSN","241","rachel@iersurgery.com",{"name":52,"role":53,"phone":19,"phoneExt":19,"email":19},"Philip Woodworth, M.D.","PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":19,"phoneExt":19,"email":19},"Reginald Bell, M.D.","SUB_INVESTIGATOR",{"type":58,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100530958","ovitex-in-paraesophageal-and-large-hiatal-hernia-repair-100530958",false,"NCT06193551","Ovitex in Paraesophageal and Large Hiatal Hernia Repair","Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)","OviPHeR","Inclusion Criteria:\n\n* 18-85 year old with PEH and appropriate surgical indication for repair\n\nExclusion Criteria:\n\n* Under 22 years of age.\n* In need of an emergency procedure.\n* Currently being treated with another investigational drug or device.\n* Have had prior gastric or esophageal surgery.\n* Have had any previous intervention for GERD.\n* Are suspected or confirmed to have esophageal or gastric cancer.\n* Have a Body Mass Index (BMI) greater than 45.\n* Cannot understand trial requirements or are unable to comply with follow-up schedule.\n* Are pregnant, nursing, or plan to become pregnant.\n* Have a mental health disorder that would interfere with your ability to follow study instructions.\n* Have suspected or known allergies to Ovitex\n* Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.","ALL","18 Years","85 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.",[78,79],"Paraesophageal Hernia","Large Hiatal Hernia",[81,82,83],"paraesophageal hiatal hernia","paraesphageal hernia","hiatal hernia","2026-02-05",{"date":86,"type":87},"2026-02-09","ACTUAL",{"date":89,"type":87},"2024-02-19",{"date":91,"type":72},"2030-06",{"name":5,"class":6},1]