Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT07062094
Eligibility Criteria:
Inclusion Criteria:
1. Subject is ≥ 18 years of age
2. Subject meets the indicated population for the device according to the Instructions for Use (IFU) including obese patients with the BMI of 30-50 kg/m2 for weight loss and patients with BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities before obesity or another surgery, unless contraindicated.
3. Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry
Exclusion Criteria:
1. Subject is planning on becoming pregnant during the one year following study device placement
2. Subject will complete follow-up visits at a location that the treating physician does not practice
3. Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
4. Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.
5. Subjects who have conditions that are contraindicated for Orbera365™ IGB System as per the IFU, including, but not limited to:
* The presence of more than one IGB at the same time.
* Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
* Potential upper gastrointestinal bleeding conditions
* A large hiatal hernia of \> 5cm or a hernia ≤ 5 cm associated with severe or intractable gastro- esophageal reflux symptoms
* A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope
* Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device.
* Gastric Mass.
* Severe coagulopathy.
* Taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants and not under medical supervision.
* Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07062094
Study Brief:
Protocol Section:
NCT07062094