Obalon in Children With Severe Obesity

Bambino Gesù Hospital and Research Institute

Status and phase: Completed; Phase 3

Conditions: Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-); Glycemic Intolerance; Altered Liver Function Tests

Treatments: Device: Swallowable Obalon® Gastric Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02137330

539/RA

539/RA Obalon (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Weight > 97° pc -CDC BMI charts-

Exclusion criteria

• Prevous abdominal surgery
• Functional gastrointestinal motility disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Obalon Arm

Experimental group

Description:

Children swalowed up to 3 intragastric balloons

Treatment:

Device: Swallowable Obalon® Gastric Balloon

Dietary and lifestyle changes Arm

No Intervention group