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

NCT03102697 | Completed

• 1 other identifier: kaiserairballoonobesity
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Metabolic Syndrome

Keywords

Intragastric balloon; obesity; metabolic syndrome; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI

  12 months

Secondary Outcomes (8)

• Rate of early explant

  12 months

• Operative complications

  Through endoscopy completion, an average of 2 hours

• Change in blood pressure

  12 months

• Changes Glycated hemoglobin (HbA1c)

  12 months

• Physical activity

  12 months

Study Arms (1)

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

Interventions

Air-filled Intragastric balloon DEVICE

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.

Also known as: Heliosphere® 600 cc and Heliosphere 720 cc

Obese individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2).

You may not qualify if:

• Morbid obesity (BMI\>40kg/m2), operative contraindications.

Sponsors & Collaborators

• Kaiser Clinic and Hospital: lead

Study Sites (1)

School of Medice of ABC

Santo André, São Paulo, Brazil

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Eduardo Grecco, MD

  School of Medicine of ABC, Santo Andre/SP Brazil

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 6, 2017
• Study Start: June 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2020
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

BR (1)