Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons in the Treatment of Obesity

Study Overview
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Brief Summary
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This is a cohort study with the objective of describing during a 12-month follow-up, weight loss in obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.

Detailed Description
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Intragastric balloon (IGB) implantation is a widely used technique to treat overweight subjects and those with mild obesity. The effectiveness of the air filled balloon (Heliosphere BAG®) in improving weight loss, reduction of BMI, percentage of body weight loss, percentage of excess weight loss and complications six months after placement is notable. Several methods are available for IGB placement and new techniques are being developed to reduce discomfort during and after the procedure. Thus, the use of an IGB as an effective method to avoid bariatric surgery is proposed. However, the precise protocol to balance complications and discomfort while maximizing weight loss is still to be established. Our secondary objectives will be: Describe the weight loss, changes in the BMI and excess weight loss between the implantation of the first IGB until its removal; Describe changes in the components of the metabolic syndrome; Describe changes in blood pressure; Estimate the rate of early explant; Describe the conditions of surgery; Describe operative complications; To describe safety in the perioperative period, in the immediate postoperative period and in the late postoperative period

Official Title
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Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons (Heliosphere Bag®) in the Treatment of Obesity: A Prospective Clinical Study

Conditions
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Obesity, Metabolic Syndrome

Intervention / Treatment
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* Device: Air-filled Intragastric balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2). Exclusion Criteria: Morbid obesity (BMI>40kg/m2), operative contraindications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese individuals<br>Obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second. | Device: Air-filled Intragastric balloon<br>* Weight loss system that consists of an air balloon that occupies space in the stomach, thus reducing the gastric capacity and leaving less volume for food.<br>* Other names: Heliosphere® 600 cc and Heliosphere 720 cc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of early explant | Rate of patients in which the balloon was extracted early | 12 months | 
| Operative complications | Rate of complications during the placement of the balloon | Through endoscopy completion, an average of 2 hours | 
| Change in blood pressure | Arterial blood pressure will be measured before and after IGB using an digital sphygmomanometer | 12 months | 
| Changes Glycated hemoglobin (HbA1c) | Blood measurements of Glycated hemoglobin (HbAq1c) will be reported in International Federation of Clinical Chemistry and Laboratory Medicine Units | 12 months | 
| Physical activity | Physical activity will be self-reported on a weekly basis | 12 months | 
| Caloric intake | Caloric intake will be self-reported on a weekly basis | 12 months | 
| Excess weight loss | Measure that relates the preoperative weight, the postoperative weight and ideal weight | 12 months | 
| Posoperative complications | Rate of postoperative complications | Through posToperative period completion, an average of 72 hours after the termination of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intragastric balloon, obesity, metabolic syndrome, bariatric surgery