Evaluation of a 6-month Intragastric Balloon

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

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.