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Not yet recruiting NCT04209842

Effectiveness Gastric Balloon in Obese Adolescents

No phase Interventional Obesity, Morbid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: gastric balloon.
Who it may be relevant to
Registry conditions: Obesity, Morbid. Basic parameters: 14 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support

Overview

Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.

Interventions

  • Device gastric balloon
    non surgical weight loss via placement of gastric balloon

Primary outcome measures

  • change from baseline weight [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI > 3.5 SD)
  • Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised

Exclusion criteria

  • Previous esophageal or gastric surgery or history of intestinal obstruction;
  • History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis
  • Hiatus hernia >5 cm or <5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion);
  • History of significant psychological disorder (permission sought from lead care giver).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Lucille Packard Children's Hospital — Palo Alto

Identifiers

NCT: NCT04209842 · 52936

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗