ObesityOrbera365NCT07062094
Safety and Effectiveness of Orbera365™ Intragastric Balloon System
An observational study of Obesity, run by Boston Scientific Corporation at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Intragastric Balloon
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Apr 2026to 1 May 2028
- How long will I take part?
- 13 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
EndoBes - Centre Medico Teknon
Barcelona
Román Turró Arau, MD
Román Turró Arau, MD
- Recruiting
Dorsia Clinic, Madrid Spain
Madrid
Elena Alcoba, +34 617 025 602, elena.alcoba@wmclinics.es
Andrés del Pozo García, MD
Czechia1 site, 1 recruiting
- Recruiting
OB Klinika
Prague
Dana Charpentier, MD
Dana Charpentier, MD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
UHCW NHS Trust
Coventry, West Midlands, CV2 2DX
Prof. Vinod Menon
Vinod Menon, Prof.
About this study
Official title: Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry
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.
Read the 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
- Being tested
- Intragastric Balloon
- Keywords
- Orbera365, Intragastric Balloon, Obesity, Orbera365™ IGB System
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start7 Apr 2026
- Primary completion7 Apr 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 13 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062094
- Sponsor's protocol ID
- E7235
- Acronym
- Orbera365
- Status last verified
- Nov 2026
- First submitted
- 24 Jun 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry
- ClinicalTrials.gov ID
- NCT07062094
- Acronym / sponsor ID
- Orbera365 / E7235
- Conditions
- Obesity
- Keywords
- Orbera365, Intragastric Balloon, Obesity, Orbera365™ IGB System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 7 Apr 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 13 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intragastric BalloonThe 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. | Device | – |
Primary outcome
Rate of Subjects with Serious Adverse Events
Time frame: Up to 12 months
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.
Rate of Treatment Completers
Time frame: Up to 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Boston Scientific Corporation at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Czechia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shay Caravaggio ((508) 683-4000, shay.caravaggio@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Subjects with Serious Adverse Events (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.