Altered Liver Function Tests Clinical Trial
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment