Actively Recruiting
Safety and Effectiveness of Orbera365™ Intragastric Balloon System
Led by Boston Scientific Corporation · Updated on 2026-04-14
200
Participants Needed
5
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of Orbera365™ Intragastric Balloon System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older
- Subject has a body mass index (BMI) between 30 and 50 kg/m2 for weight loss, or a BMI of 40 kg/m2 and above, or a BMI of 35 kg/m2 with comorbidities before obesity or other surgery
- Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry
You will not qualify if you...
- Subject plans to become pregnant during the one year after device placement
- Subject will not be able to complete follow-up visits where their treating physician practices
- Subject is unable or unwilling to take prescribed proton pump inhibitor medication for the device implant duration
- Subject has used weight loss supplements or medications within three months before baseline visit
- Subject has conditions contraindicated for the Orbera3652 IGB System per Instructions for Use, including:
- Having more than one intragastric balloon at the same time
- Inflammatory diseases of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers, cancer, or Crohn's disease
- Potential upper gastrointestinal bleeding conditions
- Large hiatal hernia greater than 5 cm, or a smaller hernia with severe reflux symptoms
- Structural abnormalities in the esophagus or pharynx that could affect device placement
- Achalasia, delayed gastric emptying symptoms, or severe motility disorders posing safety risks
- Gastric mass
- Severe bleeding disorders
- Taking aspirin, anti-inflammatory agents, anticoagulants, or other gastric irritants without medical supervision
- Prior surgery involving the esophagus, stomach, duodenum, or bariatric surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
OB Klinika
Prague, Czechia
Actively Recruiting
2
Hôpital Avicenne
Bobigny, France
Not Yet Recruiting
3
EndoBes - Centre Medico Teknon
Barcelona, Spain
Not Yet Recruiting
4
Dorsia Clinic, Madrid Spain
Madrid, Spain
Not Yet Recruiting
5
UHCW NHS Trust
Coventry, West Midlands, United Kingdom, CV2 2DX
Not Yet Recruiting
Research Team
S
Shay Caravaggio
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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