Safety and Effectiveness of Orbera365™ Intragastric Balloon System

NCT ID: NCT07062094

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-02-29

Brief Summary

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.

Detailed Description

The study's objective is to confirm the safety of the Orbera365™ Intragastric Balloon (IGB) for extended in situ dwell time (from 6 months up to 12 months). This information can be collected from standard-of-care data. Up to ten (10) sites located in Europe are planned to participate in this registry. A minimum of 100 subjects are required for the registry. A maximum of 200 subjects may be enrolled into the registry.

The study population will include Obese patients ((Body Mass Index (BMI) 30-50 kg/m2)) who have already consented to receive the Orbera365™ IGB System, who previously failed to achieve and maintain weight loss with a supervised weight-control program.

Study subjects will also include obese and super obese patients (BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk.

The duration of study participation is expected to be up to thirteen months from study placement procedure. The total treatment with the study device will be no more than 12 months from placement. A 30-day post-removal assessment will be performed following the study removal procedure. The subject will have completed the study upon the completion of the 30-day post-removal assessment, regardless of when the study removal procedure occurred.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Intragastric Balloon

The Orbera365™ IGB System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance. The IGB is placed in the stomach and filled with sterile saline, causing it to expand into a spherical shape. The filled IGB is designed to occupy space and move freely within the stomach, potentially altering appetite and satiety to achieve weight loss.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OB Klinika

Prague, , Czechia

Hôpital Avicenne

Bobigny, , France

EndoBes - Centre Medico Teknon

Barcelona, , Spain

Dorsia Clinic, Madrid Spain

Madrid, , Spain

UHCW NHS Trust

Coventry, West Midlands, United Kingdom

Countries

Czechia; France; Spain; United Kingdom

Central Contacts

Shay Caravaggio

Role: CONTACT

shay.caravaggio@bsci.com

(508) 683-4000

Facility Contacts

Dana Charpentier, MD

Role: primary

Gheorghe Airinei, MD

Role: primary

Román Turró Arau, MD

Role: primary

Andrés del Pozo García, MD

Role: primary

Prof. Vinod Menon

Role: primary

Other Identifiers

E7235

Identifier Type: -

Identifier Source: org_study_id