Effectiveness Gastric Balloon in Obese Adolescents

Stanford University

Status: Not yet enrolling

Conditions: Obesity, Morbid

Treatments: Device: gastric balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT04209842

52936

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

gastric ballon placement

Experimental group

Description:

will receive gastric balloon placed via endoscopy

Treatment:

Device: gastric balloon