Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-)Phase 3ObalonNCT02137330
Obalon in Children With Severe Obesity
A Phase 3 study testing Swallowable Obalon® Gastric Balloon in people with Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-) and Altered Liver Function Tests, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-), Altered Liver Function Tests, Glycemic Intolerance
- What is being tested?
- Swallowable Obalon® Gastric Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 3
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight > 97° pc -CDC BMI charts-
Who cannot join
- Prevous abdominal surgery
- Functional gastrointestinal motility disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance and Efficacy of the Swallowable Obalon® Gastric Balloons System in Children With Severe Obesity
The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity.
Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients.
Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.
- Conditions
- Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-), Altered Liver Function Tests, Glycemic Intolerance
- Being tested
- Swallowable Obalon® Gastric Balloon
- Keywords
- Obalon swallowable intragastric balloons, Severe obesity, Children
- Medical subject headings
- Pediatric Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowable Obalon® Gastric BalloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Obalon Arm | Experimental | Children swalowed up to 3 intragastric balloons Receives: Device: Swallowable Obalon® Gastric Balloon |
| Dietary and lifestyle changes Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss (Kg)
Measured: 3 months
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerio Nobili, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137330
- Sponsor's protocol ID
- 539/RA
- Other IDs
- 539/RA Obalon
- Acronym
- Obalon
- Status last verified
- Jul 2015
- First submitted
- 7 May 2014
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Efficacy of the Swallowable Obalon® Gastric Balloons System in Children With Severe Obesity
- ClinicalTrials.gov ID
- NCT02137330
- Acronym / sponsor ID
- Obalon / 539/RA
- Conditions
- Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-), Altered Liver Function Tests, Glycemic Intolerance
- Keywords
- Obalon swallowable intragastric balloons, Severe obesity, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 May 2014 (estimated)
- 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.
The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity.
Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients.
Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obalon Arm | Experimental | Device: Swallowable Obalon® Gastric BalloonChildren swalowed up to 3 intragastric balloons |
| Dietary and lifestyle changes Arm | No intervention | – |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Weight > 97° pc -CDC BMI charts-
Key exclusion criteria (2 listed)
- Prevous abdominal surgery
- Functional gastrointestinal motility disorders
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 |
|---|---|---|
| Swallowable Obalon® Gastric Balloon | Device | Obalon Arm |
Primary outcome
Weight loss (Kg)
Time frame: 3 months
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 months
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 22 Jul 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Swallowable Obalon® Gastric Balloon in people with Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-) and Altered Liver Function Tests, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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 2 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 22 Jul 2015. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (Kg) (time frame: 3 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 22 Jul 2015.