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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Treatment group
DeviceThe treatment group was the group with the placement of Orbera 365 plus lifestyle management
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
%TBWL (Defined as the percentage of total body weight loss)
%TBWL is defined as the percentage of total body weight loss
Time frame
At 12 months after the intervention2
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%.
Time frame
At 12 months after the interventionSponsors and contacts
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Source ClinicalTrials.gov