Effectiveness Gastric Balloon in Obese Adolescents

NCT04209842 | Not Yet Recruiting FDA Device

• 1 other identifier: 52936
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• change from baseline weight

  6 months

Study Arms (1)

gastric ballon placement

EXPERIMENTAL

will receive gastric balloon placed via endoscopy

Device: gastric balloon

Interventions

gastric balloon DEVICE

non surgical weight loss via placement of gastric balloon

Also known as: Orbera

gastric ballon placement

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Balloon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Roberto Gugig, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Monique T Barakat, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pediatrics

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)