Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
ConditionWeight Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Treatment group
Treatment groups
144 Participants
are divided into 2 treatment groupsLocations
1Shanghai Changhai Hospital200433, ShanghaiShanghai Municipality, China
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov