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

NCT ID: NCT03102697

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-12-31

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.

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

Conditions

Obesity; Metabolic Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Air-filled Intragastric balloon

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Heliosphere® 600 cc and Heliosphere 720 cc

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Clinic and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Grecco, MD

Role: STUDY_CHAIR

School of Medicine of ABC, Santo Andre/SP Brazil

Locations

School of Medice of ABC

Santo André, São Paulo, Brazil

Countries

Brazil

Other Identifiers

kaiserairballoonobesity

Identifier Type: -

Identifier Source: org_study_id