Endoscopic Treatment of Overweight and Mild Obesity Using a 12-Month Non-Adjustable Intragastric Balloon (ORBERA365)

What this Trial Is About

Researchers are studying the use of a 12-month non-adjustable intragastric balloon called Orbera365 to help overweight and class I obese adults lose weight. Obesity is a serious health issue linked to high illness and death rates. Conventional treatments like diet, exercise, and medications have not stopped obesity from increasing, and while bariatric surgery works, it is suitable for only a small number of people due to strict requirements and risks. This research explores a less invasive, reversible, and more affordable option through bariatric endoscopy using the intragastric balloon. Participants with a BMI over 27 kg/m² will have the Orbera365 balloon implanted in their stomach under general anesthesia. The balloon is filled with saline solution and methylene blue to assist with weight loss. This procedure is done at two hospital locations in Brazil. After implantation, patients will be monitored through weekly visits in the first month and then monthly visits for a full year. They will be discharged the same day with instructions to report any symptoms. During the study, researchers will collect information on participant demographics, clinical data, and any complications. They will measure total weight loss after 12 weeks and study how the balloon affects metabolic health. Safety and effectiveness will be tracked through regular check-ups and data analysis using statistical software. The study aims to improve outcomes for people struggling with overweight and mild obesity using this endoscopic treatment.

Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365