ObesityNCT03102697
Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons in the Treatment of Obesity
An observational study of Obesity and Metabolic Syndrome, run by Kaiser Clinic and Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Air-filled Intragastric balloon
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2).
Who cannot join
- Morbid obesity (BMI>40kg/m2), operative contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Air-filled Intragastric balloon
- Keywords
- Intragastric balloon, obesity, metabolic syndrome, bariatric surgery
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-filled Intragastric balloonDevice
Also called Heliosphere® 600 cc and Heliosphere 720 cc
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Air-filled Intragastric balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI
Measured: 12 months
Secondary outcomes (8)
Rate of early explant
Rate of patients in which the balloon was extracted early
Measured: 12 months
Operative complications
Rate of complications during the placement of the balloon
Measured: Through endoscopy completion, an average of 2 hours
Change in blood pressure
Arterial blood pressure will be measured before and after IGB using an digital sphygmomanometer
Measured: 12 months
Changes Glycated hemoglobin (HbA1c)
Blood measurements of Glycated hemoglobin (HbAq1c) will be reported in International Federation of Clinical Chemistry and Laboratory Medicine Units
Measured: 12 months
Physical activity
Physical activity will be self-reported on a weekly basis
Measured: 12 months
Caloric intake
Caloric intake will be self-reported on a weekly basis
Measured: 12 months
Excess weight loss
Measure that relates the preoperative weight, the postoperative weight and ideal weight
Measured: 12 months
Posoperative complications
Rate of postoperative complications
Measured: Through posToperative period completion, an average of 72 hours after the termination of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 Jun 2019
- Primary completion1 Oct 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Clinic and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Grecco, MD, Study chair, School of Medicine of ABC, Santo Andre/SP Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102697
- Sponsor's protocol ID
- kaiserairballoonobesity
- Status last verified
- Aug 2022
- First submitted
- 24 Mar 2017
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03102697
- Acronym / sponsor ID
- kaiserairballoonobesity
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Intragastric balloon, obesity, metabolic syndrome, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaiser Clinic and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese individuals | – | Device: Air-filled Intragastric balloonObese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2).
Key exclusion criteria (1 listed)
- Morbid obesity (BMI>40kg/m2), operative contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air-filled Intragastric balloonAlso: Heliosphere® 600 cc and Heliosphere 720 ccWeight 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. | Device | Obese individuals |
Primary outcome
Weight loss
Time frame: 12 months
Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI
8 secondary outcomes
Rate of early explant
Time frame: 12 months
Operative complications
Time frame: Through endoscopy completion, an average of 2 hours
Change in blood pressure
Time frame: 12 months
Changes Glycated hemoglobin (HbA1c)
Time frame: 12 months
Physical activity
Time frame: 12 months
Caloric intake
Time frame: 12 months
Excess weight loss
Time frame: 12 months
Posoperative complications
Time frame: Through posToperative period completion, an average of 72 hours after the termination of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Grecco, MD study chair
School of Medicine of ABC, Santo Andre/SP Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by Kaiser Clinic and Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.