NCT07062094

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
4 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026May 2028

First Submitted

Initial submission to the registry

June 24, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2028

Expected
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

June 24, 2025

Last Update Submit

April 10, 2026

Conditions

Obesity

Keywords

Orbera365Intragastric BalloonObesityOrbera365™ IGB System

Outcome Measures

Primary Outcomes (2)

  • Rate of Subjects with Serious Adverse Events

    The rate of subjects with serious adverse events of interest associated with the extended length of the study device in-dwell time (between 6 and 12 months) and requiringe hospitalization, endoscopic or surgical intervention, or are life-threatening. Adverse events of interest include gastric outlet obstruction, spontaneous deflation that leads to obstruction, hyperinflation, and removal complications related to airway obstruction or esophageal laceration / perforation associated with compromised balloon integrity.

    Up to 12 months

  • Rate of Treatment Completers

    The rate of Treatment Completers that achieve ≥10% percent Total Body Weight Loss (%TBWL) at time of study removal procedure. Treatment Completer is defined as maintaining device therapy for the prescribed maximum allowed in-dwell period (up to12 months) or successfully achieving weight loss goal (e.g., at least 5% TBWL) and an early device removal for a reason other than an adverse event.

    Up to 12 months

Other Outcomes (21)

  • Rate of Study Procedure-Related Adverse Events

    Up to 13 months

  • Percent Total Body Weight Loss (% TBWL) at study visits through time of removal

    Up to 12 months

  • Change in A1C

    Up to 12 months

  • +18 more other outcomes

Interventions

Intragastric BalloonDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include Obese patients (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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

OB Klinika

Prague, Czechia

RECRUITING

Hôpital Avicenne

Bobigny, France

NOT YET RECRUITING

EndoBes - Centre Medico Teknon

Barcelona, Spain

NOT YET RECRUITING

Dorsia Clinic, Madrid Spain

Madrid, Spain

NOT YET RECRUITING

UHCW NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Shay Caravaggio

CONTACT

(508) 683-4000shay.caravaggio@bsci.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
13 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 14, 2025

Study Start

April 7, 2026

Primary Completion (Estimated)

April 7, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)GB(1)CZ(1)ES(2)