A Phase 3 interventional study of Swallowable Obalon® Gastric Balloon in Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-), Altered Liver Function Tests and Glycemic Intolerance, sponsored by Bambino Gesù Hospital and Research Institute. Completed at 1 site in Italy. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-07-22.
Sponsored by Bambino Gesù Hospital and Research Institute · Phase 3, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 10 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Bambino Gesù Hospital and Research Institute is the lead sponsor of 53 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children swalowed up to 3 intragastric balloons
Device: Swallowable Obalon® Gastric Balloon
Weight loss (Kg)
Time frame: 3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 months
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Bambino Gesù Hospital and Research Institute