[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576433":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":62,"collaborators":21,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":23,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":21,"enrollmentInfo":74,"targetDuration":21,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":45,"whyStopped":21,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Kaiser Clinic and Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intragastric Ballon","EXPERIMENTAL","Endoscopic placement of Orbera365® non-adjustable intragastric balloon under general anesthesia. Device filled with 600mL saline solution with methylene blue, remaining in situ for 12 months. Weekly follow-up in first month, then monthly visits including nutritional and psychological support. Removal performed under general anesthesia after 12-month period.",[13,14],"Device: Non-Adjustable Intragastric Balloon","Device: ORBERA365",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Non-Adjustable Intragastric Balloon","Weight Loss with a 12-Month Non-Adjustable Intragastric Balloon is More Effective Compared to a 6-Month Balloon.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"ORBERA365","endoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon",[9],[27],"Intragastric Balloon",[29],{"name":30,"affiliation":31,"role":32},"Roberto Luiiz Kaiser Junior","Kaiser Clinica","STUDY_CHAIR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":21,"email":38},"Luiz Gustavo de Quadros LGQ Quadros, Doutor","CONTACT","+55 17 98138-8737","gustavo_quadros@hotmail.com",{"name":40,"role":36,"phone":41,"phoneExt":21,"email":21},"Manoel Galvão Neto","+55 (11) 97797.0239",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Faculdade ABC","RECRUITING","Santo André","São Paulo","09060-870","Brazil","BR",{"type":52,"coordinates":53},"Point",[54,55],-46.53833,-23.66389,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":21,"email":61},"Eduardo Grecco","+55 11 98162-0911","atendimento@eduardogrecco.com.br",{"type":63,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100576433","endoscopic-treatment-of-overweight-and-mild-obesity-with-orbera365-100576433",false,"NCT06785233","Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365","Endoscopic Treatment of Overweight and Mild Obesity Using a 12-month Non-adjustable Intragastric Balloon (ORBERA365)","Inclusion Criteria:\n\n* Participants with a Body Mass Index (BMI) above 27 kg\u002Fm²,\n* both sexes,\n* aged 18 years or older,\n* who consent to their participation by signing an Informed Consent Form and\n* agree to the implantation of the Orbera365® balloon at Kaiser Clinic and the Faculty of Medicine of ABC (FMABC)\u002FHospital Mario Covas.\n\nExclusion Criteria:\n\n* Relative or absolute contraindications for this procedure, such as hiatal hernia (\\> 3 cm),\n* Los Angeles grade erosive esophagitis,\n* peptic ulcer,\n* prior gastric surgery,\n* substance dependence (alcohol or illicit drugs),\n* continuous anticoagulant or anti-inflammatory therapy, and those with\n* positive urease test results until treatment is completed and evidence of resolution is provided or follow-up is lost.",true,"ALL","18 Years",{"count":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79],"NA","INTRODUCTION: Obesity is a critical health condition associated with high rates of morbidity and mortality. Conservative therapies such as dietary restriction, physical exercise, and pharmacological treatments have not prevented the rising incidence of obesity. Bariatric surgery, while effective, is limited to a relatively small proportion of the global obese population due to its strict indications and the risk of early and late postoperative complications. To address this gap, bariatric endoscopy therapies have emerged, offering less invasive, reversible, repeatable, and more cost-effective treatment options. The introduction of the intragastric balloon (IGB) in the 1980s marked the development of a minimally invasive, non-surgical, and safe procedure with low complication rates. OBJECTIVE: To evaluate the weight loss efficacy in overweight and Class I obese patients through the implantation of a 12-month non-adjustable intragastric balloon. METHODS: This prospective study involved overweight patients (BMI \\> 27 kg\u002Fm²) undergoing intragastric balloon treatment and multidisciplinary follow-up at the Bariatric Endoscopy Clinic of the Faculty of Medicine of ABC (FMABC) over a 12-month period. EXPECTED RESULTS: Weight loss following intragastric balloon implantation and improvement in metabolic indices.",[82,83],"Obesity","Obesity, Morbid",[85,27],"obesity","2025-01-17",{"date":88,"type":89},"2025-01-21","ACTUAL",{"date":91,"type":76},"2025-01",{"date":93,"type":76},"2026-02",{"name":5,"class":6},1]