Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
10 participants
INTERVENTIONAL
2014-01-31
2014-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Obalon Arm
Children swalowed up to 3 intragastric balloons
Swallowable Obalon® Gastric Balloon
Dietary and lifestyle changes Arm
No interventions assigned to this group
Interventions
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Swallowable Obalon® Gastric Balloon
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Functional gastrointestinal motility disorders
9 Years
17 Years
ALL
No
Sponsors
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Bambino Gesù Hospital and Research Institute
OTHER
Responsible Party
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Valerio Nobili
MD
Locations
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Bambino Gesù Children Hospital
Rome, Italy, Italy
Countries
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Other Identifiers
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539/RA Obalon
Identifier Type: REGISTRY
Identifier Source: secondary_id
539/RA
Identifier Type: -
Identifier Source: org_study_id
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