[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499291":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":29,"responsibleParty":47,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Military University Hospital, Prague","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients receiving Stretta","ACTIVE_COMPARATOR",null,[13,14],"Procedure: Radiofrequency Energy to the LES (Stretta Procedure)","Device: Stretta",{"label":16,"type":17,"description":11,"interventionNames":11},"Patients receiving Conservative therapy\u002FPPI","NO_INTERVENTION",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","Radiofrequency Energy to the LES (Stretta Procedure)","The Stretta procedure is an endoscopic treatment performed under general anesthesia. It utilizes radiofrequency (RF) energy delivered to the lower esophageal sphincter (LES) and the gastric cardia to enhance the antireflux barrier.",[9],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DEVICE","Stretta","Stretta is a FDA approved device for the management of GERD.",[9],[30],{"facility":31,"status":32,"city":33,"state":11,"zip":11,"country":34,"countryCode":11,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Military University Hospital Prague","RECRUITING","Prague","Czechia",{"type":36,"coordinates":37},"Point",[38,39],14.42076,50.08804,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Katerina Kostalova, MD","CONTACT","+420973203076","katerina.kostalova@uvn.cz",{"type":48,"investigatorFullName":43,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100499291","stretta-versus-conservative-treatment-100499291",false,"NCT05781347","Stretta Versus Conservative Treatment","Endoscopic Treatment of Gastro-esophageal Reflux Disease with Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment, Prospective Randomized Study","Inclusion Criteria:\n\nVerified symptomatic GERD despite PPI use, with persistent symptoms, desire to discontinue PPIs, or intolerance to them.\n\nPathological gastroesophageal reflux confirmed by positive 24-hour pH-metry with impedance.\n\nNormal findings on high-resolution esophageal manometry (HRM) according to CCv4.0.\n\nAge ≥ 18 years. Signed informed consent for participation in the trial and invasive procedures.\n\nExclusion Criteria:\n\nActive severe reflux esophagitis (Los Angeles classification grade C or D). Barrett's esophagus. Esophageal peptic stricture or eosinophilic esophagitis. Hiatal hernia ≥ 2 cm. Malignancies. Abnormal findings on high-resolution esophageal manometry. Esophageal or subcardial varices. Pregnancy. Severe comorbidities or increased perioperative risk. Age \\> 70 years due to increased perioperative risk and common comorbidities. Symptoms primarily attributable to functional dyspepsia, significant anxiety, or depression, with overlap to other disorders of gut-brain interaction (DGBI).","ALL","18 Years","70 Years",{"count":61,"type":62},50,"ESTIMATED","INTERVENTIONAL",[65],"NA","Gastroesophageal reflux disease (GERD) is one of the most common diseases of the gastrointestinal tract. Obesity is a significant risk factor for GERD; however, treatment outcomes in obese patients remain challenging. In the Czech Republic, therapeutic options are currently limited to conservative treatment, including pharmacotherapy and lifestyle modifications, or surgical interventions, both of which have known limitations. Stretta is a minimally invasive endoscopic therapy using radiofrequency energy delivered to the esophagogastric junction (EGJ) and cardia, aimed at enhancing the antireflux barrier.\n\nThis study evaluates the effectiveness and safety of the Stretta procedure compared to conservative treatment in managing GERD. Initially designed to compare outcomes between obese and non-obese populations, the study was expanded to include all GERD patients due to recruitment challenges and the need to meet strict eligibility criteria. These criteria ensure reliable results by focusing on patients with confirmed pathological GERD while excluding those with hiatal hernias ≥ 2 cm, severe esophagitis, or functional esophageal disorders such as hypersensitivity. The study aims to provide comprehensive data on the use of Stretta in the Czech Republic and its role in GERD management.",[68],"GERD","2025-01-05",{"date":71,"type":72},"2025-01-07","ACTUAL",{"date":74,"type":72},"2022-09-01",{"date":76,"type":62},"2026-03-31",{"name":5,"class":6},1]