Weight LossNCT07195708
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
A study testing Treatment group in people with Weight Loss, run by Boston Scientific Corporation at 1 site in China.
Trial summary
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- Treatment group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- The subject is diagnosed with obesity, and the body mass index (BMI) is ≥28 kg/m² and ≤50 kg/m².
- The subject is aged ≥18 years.
- Failed previous conservative weight loss alternatives (e.g., supervised diet, exercise, and behavior modification programs).
- Willing to avoid the use of medical devices, medications, or other substances for weight loss purposes during the study period.
- Willing to avoid the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the study period, including aspirin, diclofenac, ibuprofen, naproxen, or other known gastric-irritating drugs.
- Able to take proton pump inhibitors (PPIs), antiemetics, and other medications as prescribed by the researcher.
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- Capable of walking completely independently, with no severe chronic orthopedic diseases.
- Willing to undergo gastroscopy.
- Voluntarily participate in the trial, sign the informed consent form, and be willing to comply with study requirements, including follow-ups.
Who cannot join
- Prior surgery involving the esophagus, stomach, and duodenum.
- Prior bariatric surgery or intragastric medical devices for weight loss.
- A large hiatal hernia of > 5 cm or a hernia ≤ 5 cm associated with severe or intractable gastroesophageal reflux symptoms.
- Patients who have a history of gastrointestinal obstruction, adhesive peritonitis.
- Any active inflammatory or neoplastic disease of the gastrointestinal tract. among these, inflammatory diseases include esophagitis, gastric ulcer, duodenal ulcer, and specific types (e.g., Crohn's disease), while neoplastic diseases include cancer, and the doctor judges that such conditions may affect the use of Orbera365.
- Potential upper gastrointestinal bleeding disorders, such as esophageal or gastric varices, congenital or acquired intestinal capillary ectasia, or other congenital gastrointestinal abnormalities, such as atresia or stenosis that precludes the usage for Orbera365.
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- 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 that precludes the usage for Orbera365.
- 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.
- Positive result in the Helicobacter pylori breath test (Patients who turn negative after regular treatment can participate in this clinical trial).
- History or symptoms of uncontrolled or unstable thyroid disease.
- Abnormal coagulation with an INR > 1.5 that cannot be corrected (as judged by a physician) or requiring continuous full anticoagulant therapy, and/or the presence of any underlying disease associated with a high risk of bleeding.
- Hepatic insufficiency or liver cirrhosis, including: acute liver failure, advanced liver cirrhosis with encephalopathy, muscle atrophy, and generalized edema. severe esophageal varices with red signs and gastric varices. severe portal hypertensive gastropathy with or without gastric antral vascular ectasia.
- Anemia: For females, hemoglobin (Hgb) < 110 g/L. for males, hemoglobin (Hgb) < 120 g/L.
- Patients with known or suspected allergic reactions to the materials contained in Orbera365.
- Any other physical conditions that do not allow for elective endoscopy, such as poor overall health or a history and/or symptoms of severe kidney, liver, heart, and/or lung diseases. severe or uncontrolled mental illnesses or abnormalities that may affect the patient's ability to understand or comply with follow-up visits and the removal of the device 12 months later.
- Patients who are unable or unwilling to take the prescribed proton pump inhibitor medications during the device placement period.
- Patients who are unwilling to avoid any reconstructive and/or plastic surgeries that may affect weight during the study period, such as mammoplasty and liposuction.
- Patients who are unwilling to participate in the established medical supervision diet and behavior modification program and undergo regular medical follow-ups.
- Patients who are receiving treatment with anticoagulants, antiplatelet drugs, immunosuppressants, non-steroidal anti-inflammatory drugs (NSAIDs), or other drugs known to irritate the gastroduodenal mucosa or reduce gastrointestinal motility and/or are unwilling to discontinue such concomitant medications. prescription or over-the-counter weight loss drugs, drugs known to cause significant weight gain or loss (such as anesthetics, opioids, or benzodiazepines), insulin, antiepileptic drugs, antiarrhythmic drugs (such as amiodarone). other drugs that may cause weight changes, including drugs that can significantly increase weight (such as glucocorticoids, insulin secretagogues, thiazolidinediones, atypical antipsychotics, sodium valproate, lamotrigine, antidepressants, etc.), and drugs that can significantly reduce weight (such as glucagon-like peptide-1 receptor agonists, α-glucosidase inhibitors, topiramate, fluoxetine, bupropion, zonisamide, etc.).
- Alcohol abuse and/or drug abuse.
- Evidence of untreated mental or eating disorders, such as major depressive disorder, schizophrenia, substance abuse, binge eating disorder, or bulimia nervosa.
- Poor overall health, presence of specific diseases, or situations that, in the judgment of the researcher during evaluation and/or device placement, may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and/or balloon placement, or may significantly interfere with the subject's participation in the study (for example, having acquired immunodeficiency syndrome or hepatitis C within the past 5 years).
- Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).
- Currently participating in a study of investigational drugs or devices, or having participated in such a study within 30 days before participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhaoshen Li contact
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zhaoshen Li, Dr, 13901960921 ext. +86, lzsl@vip.163.com
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of the Orbera365 Intragastric Balloon System in Obese Patients
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
Read the detailed description
The study is a prospective, multicenter, randomized controlled, non-blinded trial.
The treatment group was the group with the placement of Orbera 365 plus lifestyle management, while the control group was the lifestyle management group. The central randomization system was adopted to randomly assign the research subjects into the experimental group and the control group. The subjects were enrolled at a 1:1 ratio, with 72 cases in each group, making a total of 144 cases.
The subjects in the treatment group will be followed up until 6 months after the balloon removal or 12 months after the endoscopy procedure, whichever comes later. The control group is planned to receive a 12-month lifestyle intervention, and the maximum follow-up period is up to 18 months.
- Conditions
- Weight Loss
- Being tested
- Treatment group
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment groupDevice
The treatment group was the group with the placement of Orbera 365 plus lifestyle management
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Orbera365+Lifestyle management Receives: Device: Treatment group |
| Control group | No intervention | Lifestyle management |
What is being measured
The primary outcome is the main question the study is designed to answer.
%TBWL (Defined as the percentage of total body weight loss)
%TBWL is defined as the percentage of total body weight loss
Measured: At 12 months after the intervention
The response rate at the 12th month after the intervention
Response is defined as having a percentage of total body weight loss (%TBWL) of ≥ 5%.
Measured: At 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start3 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, Dr, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195708
- Sponsor's protocol ID
- E7236
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of the Orbera365 Intragastric Balloon System in Obese Patients
- ClinicalTrials.gov ID
- NCT07195708
- Acronym / sponsor ID
- E7236
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Sep 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.
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
Detailed description
The study is a prospective, multicenter, randomized controlled, non-blinded trial.
The treatment group was the group with the placement of Orbera 365 plus lifestyle management, while the control group was the lifestyle management group. The central randomization system was adopted to randomly assign the research subjects into the experimental group and the control group. The subjects were enrolled at a 1:1 ratio, with 72 cases in each group, making a total of 144 cases.
The subjects in the treatment group will be followed up until 6 months after the balloon removal or 12 months after the endoscopy procedure, whichever comes later. The control group is planned to receive a 12-month lifestyle intervention, and the maximum follow-up period is up to 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Treatment groupOrbera365+Lifestyle management |
| Control group | No intervention | –Lifestyle management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject is diagnosed with obesity, and the body mass index (BMI) is ≥28 kg/m² and ≤50 kg/m².
- The subject is aged ≥18 years.
- Failed previous conservative weight loss alternatives (e.g., supervised diet, exercise, and behavior modification programs).
- Willing to avoid the use of medical devices, medications, or other substances for weight loss purposes during the study period.
- Willing to avoid the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the study period, including aspirin, diclofenac, ibuprofen, naproxen, or other known gastric-irritating drugs.
Key exclusion criteria (24 listed)
- Prior surgery involving the esophagus, stomach, and duodenum.
- Prior bariatric surgery or intragastric medical devices for weight loss.
- A large hiatal hernia of > 5 cm or a hernia ≤ 5 cm associated with severe or intractable gastroesophageal reflux symptoms.
- Patients who have a history of gastrointestinal obstruction, adhesive peritonitis.
- Any active inflammatory or neoplastic disease of the gastrointestinal tract. among these, inflammatory diseases include esophagitis, gastric ulcer, duodenal ulcer, and specific types (e.g., Crohn's disease), while neoplastic diseases include cancer, and the doctor judges that such conditions may affect the use of Orbera365.
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 |
|---|---|---|
| Treatment groupThe treatment group was the group with the placement of Orbera 365 plus lifestyle management | Device | Treatment group |
Primary outcome
%TBWL (Defined as the percentage of total body weight loss)
Time frame: At 12 months after the intervention
%TBWL is defined as the percentage of total body weight loss
The response rate at the 12th month after the intervention
Time frame: At 12 months after the intervention
Response is defined as having a percentage of total body weight loss (%TBWL) of ≥ 5%.
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 27 Oct 2026.
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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.
Zhaoshen Li contact
Zhaoshen Li, Dr principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group in people with Weight Loss, run by Boston Scientific Corporation at 1 site in China.
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 9 inclusion and 24 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Zhaoshen Li, Dr (13901960921 ext. +86, lzsl@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%TBWL (Defined as the percentage of total body weight loss) (time frame: At 12 months after the intervention). 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 27 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.