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NCT Number: NCT04209842

Effectiveness Gastric Balloon in Obese Adolescents

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gastric Balloon

Device

non surgical weight loss via placement of gastric balloon

Other names: Orbera

Primary outcomes

  1. change from baseline weight

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2019
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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