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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102697
• Other study ID #: kaiserairballoonobesity
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2022
• Source: Kaiser Clinic and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Brazil	School of Medice of ABC	Santo Andre	Sao Paolo

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Clinic and Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI	12 months
Secondary	Rate of early explant	Rate of patients in which the balloon was extracted early	12 months
Secondary	Operative complications	Rate of complications during the placement of the balloon	Through endoscopy completion, an average of 2 hours
Secondary	Change in blood pressure	Arterial blood pressure will be measured before and after IGB using an digital sphygmomanometer	12 months
Secondary	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
Secondary	Physical activity	Physical activity will be self-reported on a weekly basis	12 months
Secondary	Caloric intake	Caloric intake will be self-reported on a weekly basis	12 months
Secondary	Excess weight loss	Measure that relates the preoperative weight, the postoperative weight and ideal weight	12 months
Secondary	Posoperative complications	Rate of postoperative complications	Through posToperative period completion, an average of 72 hours after the termination of surgery