Safety and Effectiveness of Orbera365™ Intragastric Balloon System
ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ Intragastric Balloon (IGB) System for weight loss. Subjects that agree to participate in the registry will have data reported associated with standard of care weight management visits during the time the device is implanted (in-dwell period), with an additional visit 30 days after the removal procedure.
Eligibility criteria
Qualifiers
Subject is ≥ 18 years of age
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.
Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry
Disqualifiers
Subject is planning on becoming pregnant during the one year following study device placement
Subject will complete follow-up visits at a location that the treating physician does not practice
Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.
Trial design
Treatments tested in this trial
- Intragastric Balloon
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov