Safety and Effectiveness of Orbera365™ Intragastric Balloon System
ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Intragastric Balloon
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 12 months2
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.
Time frame
Up to 12 monthsOther outcomes
1
Rate of Study Procedure-Related Adverse Events
Continuous assessment of safety of Orbera365™ IGB System by summarizing the occurrence of study device and study procedure-related Adverse Events through 30 days post balloon removal.
Time frame
Up to 13 months2
Percent Total Body Weight Loss (% TBWL) at study visits through time of removal
Percent Total Body Weight Loss (% TBWL) at study visits through time of removal (no more than 12 months).
Time frame
Up to 12 months3
Change in A1C
Change in Hemoglobin A1C from baseline
Time frame
Up to 12 months4
Change in Insulin
Change in Insulin from baseline
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov