Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')

NCT07195708 | Not Yet Recruiting

• 1 other identifier: E7236
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

• %TBWL (Defined as the percentage of total body weight loss)

  %TBWL is defined as the percentage of total body weight loss

  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%.

  At 12 months after the intervention

Study Arms (2)

Treatment group

EXPERIMENTAL

Orbera365+Lifestyle management

Device: Treatment group

Control group

NO INTERVENTION

Lifestyle management

Interventions

Treatment group DEVICE

The treatment group was the group with the placement of Orbera 365 plus lifestyle management

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: September 29, 2025
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04