Evaluation of a 6-month Intragastric Balloon

Официальное название

Evaluation of the Safety and Efficacy of a 6-month Intragastric Balloon

Обзор

Post-market observational, adaptive, single-arm clinical study to evaluate the percentage of total weight loss after treatment with an intragastric balloon. Patients will be followed for 6 months after the device is installed.

Подробное описание

Forty-six overweight patients over 18 years of age with a BMI of 27 kg/m2 or greater who are considered suitable for intragastric balloon placement will be included. The primary outcome will be the assessment of the percentage of total weight loss (%WL) at 6 months. Patients will be screened in an outpatient setting at the participating research center. All participants who meet the eligibility criteria will be invited to participate in the study, which includes a screening visit, standard intragastric balloon placement procedure, and follow-up visits.

Первичные конечные точки

• Evaluation of the percentage of total weight loss (%PPT) in 6 months after installation of the intragastric balloon [Срок оценки: From the installation of the balloon to the end of treatment at 6 months]

Вторичные конечные точки (4)

• Number of Adverse event occurrence assessed by clinical evaluation [Срок оценки: From the installation of the balloon to the end of treatment at 6 months]
• Weight changes 6 months after installation of the balloon assessed by anthropometric balance in in-person consultations [Срок оценки: From the installation of the balloon to the end of treatment at 6 months]
• BMI changes 6 months after the installation of the intragastric balloon assessed by BMI calculation in in-person clinical consultations [Срок оценки: From the installation of the balloon to the end of treatment at 6 months]
• Abdominal circumference changes 6 months after the intragastric balloon installation assessed by measuring tape in in-person clinical consultations [Срок оценки: From the installation of the balloon to the end of treatment at 6 months]

Критерии участия

Критерии включения

• Signed informed consent form;
• Age 18 or older;
• Both sexes;
• Being overweight, with a Body Mass Index (BMI) of 27 kg/m2 or higher;
• Being able to follow the protocol monitoring requirements;
• Adhering to the diet recommended by the nutrition professional;
• Presenting reasonable expectations of weight loss, at least 10% of baseline weight.

Критерии исключения

• Pregnant women or women during the breastfeeding period;
• People unable or unwilling to comply with restrictions regarding diet or medical monitoring and their respective guidelines during the program for use of the Intragastric Balloon;
• People with severe kidney and/or liver diseases;
• Patients who have undergone previous gastric surgery;
• Patients with inflammatory diseases of the gastrointestinal tract, gastric ulcer, duodenal ulcer or specific inflammations, such as Crohn\'s disease, or with a propensity for gastrointestinal bleeding in the upper tract, such as esophageal or gastric varices, or acquired intestinal telangiectasia;
• People with severe cardiopulmonary or organic disorders;
• People with congenital or acquired anomalies of the gastrointestinal tract, such as atresia and stenosis; with large hiatal hernia;
• Drug addicts in general;
• Patients not committed to adhering to treatment and medical recommendations, including nutritional guidance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

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• Caballero B. Humans against Obesity: Who Will Win? Adv Nutr. 2019 Jan 1;10(suppl_1):S4-S9. doi: 10.1093/advances/nmy055. PMID 30721956
• Lee KG, Nam SJ, Choi HS, Lee HL, Yoon JH, Park CH, Kim KO, Kim DH, Kim JW, Sohn W, Jung SH; Korean Research Group for Endoscopic Management of Metabolic Disorder and Obesity. Efficacy and safety of intragastric balloon for obesity in Korea. Clin Endosc. 2023 May;56(3):333-339. doi: 10.5946/ce.2022.143. Epub 2022 Dec 13. PMID 36510655
• Martinez-Brocca MA, Belda O, Parejo J, Jimenez L, del Valle A, Pereira JL, Garcia-Pesquera F, Astorga R, Leal-Cerro A, Garcia-Luna PP. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg. 2007 May;17(5):649-57. doi: 10.1007/s11695-007-9109-z. PMID 17658025
• Genco A, Cipriano M, Bacci V, Cuzzolaro M, Materia A, Raparelli L, Docimo C, Lorenzo M, Basso N. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond). 2006 Jan;30(1):129-33. doi: 10.1038/sj.ijo.0803094. PMID 16189503
• Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, Mendonca LM, Godoy-Matos AF, Lopes AJ, Farias ML. Impact of a 6-month treatment with intragastric balloon on body composition and psychopathological profile in obese individuals with metabolic syndrome. Diabetol Metab Syndr. 2016 Dec 19;8:81. doi: 10.1186/s13098-016-0197-6. eCollection 2016. PMID 28031749
• Buzga M, Evzen M, Pavel K, Tomas K, Vladislava Z, Pavel Z, Svagera Z. Effects of the intragastric balloon MedSil on weight loss, fat tissue, lipid metabolism, and hormones involved in energy balance. Obes Surg. 2014 Jun;24(6):909-15. doi: 10.1007/s11695-014-1191-4. PMID 24488758
• Moore RL, Eaton L, Ellner J. Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting. Obes Surg. 2020 Nov;30(11):4267-4274. doi: 10.1007/s11695-020-04798-5. PMID 32617919

Идентификаторы

NCT: NCT06585371 · MEDICONE_01_2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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