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Completed

NCT Number: NCT03102697

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Medice of ABC

Santo André, São Paulo, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Heliosphere® 600 cc and Heliosphere 720 cc

Primary outcomes

  1. Weight loss

    Time frame: 12 months

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

Secondary outcomes

  1. Rate of early explant

    Time frame: 12 months

    Rate of patients in which the balloon was extracted early

  2. Operative complications

    Time frame: Through endoscopy completion, an average of 2 hours

    Rate of complications during the placement of the balloon

  3. Change in blood pressure

    Time frame: 12 months

    Arterial blood pressure will be measured before and after IGB using an digital sphygmomanometer

  4. Changes Glycated hemoglobin (HbA1c)

    Time frame: 12 months

    Blood measurements of Glycated hemoglobin (HbAq1c) will be reported in International Federation of Clinical Chemistry and Laboratory Medicine Units

  5. Physical activity

    Time frame: 12 months

    Physical activity will be self-reported on a weekly basis

  6. Caloric intake

    Time frame: 12 months

    Caloric intake will be self-reported on a weekly basis

  7. Excess weight loss

    Time frame: 12 months

    Measure that relates the preoperative weight, the postoperative weight and ideal weight

  8. Posoperative complications

    Time frame: Through posToperative period completion, an average of 72 hours after the termination of surgery

    Rate of postoperative complications

Sponsors and collaborators

Lead sponsor

Kaiser Clinic and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 6, 2017
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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