Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

Launched by KAISER CLINIC AND HOSPITAL · Jan 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for people who are overweight or mildly obese. The treatment involves a procedure called the ORBERA365 intragastric balloon, which is a non-surgical, minimally invasive method to help with weight loss. The balloon is placed in the stomach to help patients feel fuller, encouraging them to eat less. The goal of the study is to see how effective this balloon is for helping people lose weight over a 12-month period, while also improving their overall health.

To participate in this trial, you need to be at least 18 years old and have a Body Mass Index (BMI) of over 27, which indicates being overweight. The trial is open to both men and women. However, certain health conditions may prevent you from joining, such as previous stomach surgeries or certain digestive issues. If you qualify and choose to participate, you can expect to receive support and follow-up care from a team of healthcare professionals throughout the year. This could be a great opportunity for those looking for a less invasive way to manage their weight.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with a Body Mass Index (BMI) above 27 kg/m²,
• • both sexes,
• • aged 18 years or older,
• • who consent to their participation by signing an Informed Consent Form and
• • agree to the implantation of the Orbera365® balloon at Kaiser Clinic and the Faculty of Medicine of ABC (FMABC)/Hospital Mario Covas.
• Exclusion Criteria:
• • Relative or absolute contraindications for this procedure, such as hiatal hernia (\> 3 cm),
• • Los Angeles grade erosive esophagitis,
• • peptic ulcer,
• • prior gastric surgery,
• • substance dependence (alcohol or illicit drugs),
• • continuous anticoagulant or anti-inflammatory therapy, and those with
• • positive urease test results until treatment is completed and evidence of resolution is provided or follow-up is lost.