Plain-English translation of NCT06785233 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Obesity research guide →This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study is testing the ORBERA365, a soft, non-adjustable balloon that is placed inside your stomach to help reduce hunger and help you lose weight. The balloon stays in your stomach for 12 months and is then removed. Researchers want to see how much weight people lose and whether this treatment is safe and effective for people who are overweight or have mild obesity.
Currently, people struggling with overweight and mild obesity have limited options between lifestyle changes alone and major weight-loss surgery. This trial exists to see whether this less invasive balloon treatment could be an effective middle-ground option to help people lose weight.
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You will have the balloon placed during a procedure under general anesthesia at one of two hospitals in São Paulo, Brazil. After the procedure, you'll go home the same day with a companion. For the first month, you'll have weekly check-in visits with your doctor, then monthly visits for the remaining 11 months—totaling one year of follow-up. During these visits, you'll receive nutritional and psychological support, and your weight and health will be monitored. After 12 months, the balloon will be removed in a similar procedure under anesthesia.
AI-generated summary from trial data · Jun 16, 2026 · Not medical advice
Brazil