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

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ClinicalTrials.gov Identifier: NCT03102697
Recruitment Status : Unknown
Verified March 2017 by Kaiser Clinic and Hospital.
Recruitment status was:  Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kaiser Clinic and Hospital

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.

Condition or disease Intervention/treatment
Obesity Metabolic Syndrome 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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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 Name: Heliosphere® 600 cc and Heliosphere 720 cc




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102697


Contacts
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Contact: Eduardo Grecco, MD +55-11-98162-0911 dreduardogrecco@gmail.com
Contact: Thiago Souza, PhD +55-11-97524-6754 tsouzahc@gmail.com

Locations
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Brazil
School of Medice of ABC Recruiting
Santo Andre, Sao Paolo, Brazil
Contact: Thiago Souza, PhD    +55-11-97524-6754    tsouzahc@gmail.com   
Contact: Eduardo Grecco, MD    +55-11-98162-0911    dreduardogrecco@gmail.com   
Sponsors and Collaborators
Kaiser Clinic and Hospital
Investigators
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Study Chair: Eduardo Grecco, MD School of Medicine of ABC, Santo Andre/SP Brazil

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Responsible Party: Kaiser Clinic and Hospital
ClinicalTrials.gov Identifier: NCT03102697     History of Changes
Other Study ID Numbers: kaiserairballoonobesity
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Clinic and Hospital:
Intragastric balloon
obesity
metabolic syndrome
bariatric surgery

Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases