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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Device: Air-filled Intragastric balloon

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Brazil
  • Sao Paolo
    • Santo Andre, Sao Paolo, Brazil
      • School of Medice of ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Obese or overweight individuals eligible for gastric balloon placement and with no contraindications for the procedure will be recruited from the Mario Covas Hospital and the Kaiser Day Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese individuals; 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; 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.; Other Names: Heliosphere® 600 cc and Heliosphere 720 cc

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Clinic and Hospital
• Investigators: Study Chair: Eduardo Grecco, MD, School of Medicine of ABC, Santo Andre/SP Brazil

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; metabolic syndrome; Intragastric balloon
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome
• Other Study ID Numbers: kaiserairballoonobesity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No