[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mater Olbia Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100428075","bariatric-endoscopy-for-treatment-of-obesity-100428075",false,"NCT04854317","Bariatric Endoscopy for Treatment of Obesity","Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial","Inclusion Criteria:\n\n* age \\> 18 years old;\n* acceptance of written informed consent to undergo an EG;\n* capability to understand and comply with the study protocol;\n* obesity: a BMI of 30-34.99 kg\u002Fm2 with previous failed attempts at diet and with obesity-related diseases, a BMI of 35-39.99 kg\u002Fm2 with previous failed attempts at diet and with or without obesity-related diseases, a BMI of 40-44.99 kg\u002Fm2 with previous failed attempts at diet and with or without obesity-related diseases not fit for surgery.\n\nExclusion Criteria:\n\n* patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason;\n* patients suffering from any condition which precludes compliance with study instructions;\n* patients who underwent previous attempts at surgical or endoscopic bariatric therapy;\n* patient has any allergy or other known contraindication or intolerance to the medications used in the study;\n* women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice methods of contraception;\n* patient suffers from a life threatening condition.","ALL","18 Years","70 Years",{"count":20,"type":21},189,"ESTIMATED","INTERVENTIONAL",[24],"NA","A single-center, randomized trial will be conducted in order to compare three Endoscopic Gastroplasty (EG) techniques in obese patients (BMI 30-44.99 kg\u002Fm2) at Gastroenterology and Gastrointestinal Endoscopy Unit, Mater Olbia Hospital, Qatar Foundation Endowment \\& Gemelli Foundation, Italy in period June 2020 - August 2024, with the aim to compare the efficacy and safety of these procedures.",[27],"Obesity",[29,30,31,32,33],"Weight","Obese","Endoscopic Sleeve Gastroplasty","Endoluminal Vertical Gastroplasty","Primary Obesity Surgical Endolumenal 2","RECRUITING","2025-01-30",{"date":37,"type":38},"2025-02-03","ACTUAL",{"date":40,"type":38},"2020-06-19",{"date":42,"type":21},"2025-02",{"name":44,"class":45},"Mater Olbia Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100567850","intragastric-balloon-for-treatment-of-overweight-and-obesity-which-is-the-best-filling-volume-100567850","NCT06673550","Intragastric Balloon for Treatment of Overweight and Obesity: Which is the Best Filling Volume?","Fluid-filled Intragastric Balloon's Filling Volume At 500, 600, or 700 Ml for Treatment of Overweight and Obesity: Which is the Magic Number? a Single Centre Randomized Study","Inclusion Criteria:\n\n* age \\> 18 years, obesity grade I-III, or overweight with at least one obesity-related comorbidity\n\nExclusion Criteria:\n\n* history of bariatric surgery or endoscopy, allergies to methylene blue, childbearing or not willing to participate or comply with follow-up",true,"80 Years",{"count":57,"type":21},156,[24],"TITLE: Randomized study conducted in a single center, with the aim of comparing the three main filling volumes of the intragastric balloon in overweight or obese patients (BMI \\>27 and \\\u003C60 kg\u002Fm2).\n\nOBJECTIVE: To establish the efficacy and safety of the intragastric balloon inflated to different volumes in patients who are candidates for balloon placement for overweight or obesity. To date there is no well-defined filling volume and each Endoscopist inflates the balloon to a random volume between 500 and 700 ml according to the experience acquired, but without a clear rationale.\n\nDESIGN: All overweight or obese patients with an indication for intragastric balloon placement will be preliminarily examined by a multidisciplinary team composed of a gastroeterologist, surgeon, nutritionist, psychologist, radiologist and endocrinologist.\n\nBefore each bariatric procedure, patients will undergo a psychometric and nutritional evaluation in order to identify any psychopathological conditions that contraindicate the operation.\n\nThe enrolled patients will be randomly divided to be candidates for balloon placement:\n\n* 1\u002F3 of patients will undergo treatment with an intragastric balloon inflated with 500 ml of saline solution and methylene blue, a space-occupying technique, which will be left in place for 1 year;\n* 1\u002F3 of patients will undergo treatment with an intragastric balloon inflated with 600 ml of saline solution and methylene blue;\n* 1\u002F3 of patients will undergo treatment with an intragastric balloon inflated with 700 ml of saline solution and methylene blue.\n\nAll balloons will remain in place for 6 months, as per the instructions provided in the product technical data sheet.\n\nAll the techniques described have already been widely validated by the scientific literature and are commonly used in bariatric endoscopy.\n\nSample size: assuming a significant level of 0.05, to detect as significant a medium effect size (f=0.25) with a power of 80% performing an ANOVA model we will need to enrol 156 patients (52 in each group). Taking into account a possible 5% of drop-out at the enrollment, the total number of patients will be around 165 (55 per group).\n\nINFORMED CONSENT: Will be obtained upon first registration of the patient in the computer archive, as required by the hospital computer system, for access to personal data, which will be then used anonymously.",[61],"Obese Patients",[63],"Intragastric balloon","2024-11-20",{"date":66,"type":38},"2024-11-22",{"date":68,"type":38},"2022-08-20",{"date":70,"type":21},"2025-06",{"name":44,"class":45},""]