Obesity Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are 18 years of age or older.
- People whose body mass index (BMI — a measure of body weight relative to height) falls within the range required for the device: a BMI of 30–50 for weight loss purposes, or a BMI of 40 or above, or a BMI of 35 or above with other weight-related health conditions, before obesity or other surgery — unless there is a medical reason the device cannot be used (confirm with trial site).
- People who are able to read, understand, and sign a written consent form to take part in the registry.
Who may not be able to join:
- People who are planning to become pregnant during the year after the device is placed.
- People whose follow-up visits would need to take place at a location where the treating doctor does not practice.
- People who are unable or unwilling to take a prescribed stomach-acid-reducing medication (called a proton pump inhibitor) for the entire time the device is in place.
- People who are currently using, or have used in the three months before the baseline visit, any over-the-counter or prescription weight loss supplements or medications.
- People who have certain health conditions that make the Orbera365™ balloon device medically unsuitable, including but not limited to: already having a balloon device in the stomach; inflammatory conditions of the digestive tract such as esophagitis, stomach or duodenal ulcers, cancer, or Crohn's disease; conditions that could cause bleeding in the upper digestive tract; a large hiatal hernia (more than 5 cm), or a smaller hernia with severe reflux symptoms; a narrowing or pouch in the throat or esophagus that could block the procedure; swallowing or stomach-emptying disorders; a mass in the stomach; a serious blood-clotting disorder; use of aspirin, anti-inflammatory drugs, blood thinners, or other stomach-irritating medications without medical supervision; or prior surgery involving the esophagus, stomach, duodenum, or any previous weight-loss surgery.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: (508) 683-4000
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Rate of Subjects with Serious Adverse Events; Rate of Treatment Completers
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.