Effectiveness Gastric Balloon in Obese Adolescents

NCT ID: NCT04209842

Last Updated: 2023-12-21

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gastric ballon placement

will receive gastric balloon placed via endoscopy

Group Type EXPERIMENTAL

gastric balloon

Intervention Type DEVICE

non surgical weight loss via placement of gastric balloon

Interventions

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gastric balloon

non surgical weight loss via placement of gastric balloon

Intervention Type DEVICE

Other Intervention Names

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Orbera

Eligibility Criteria

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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).
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Gugig

professor of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto Gugig, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Monique T Barakat, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Lucille Packard Children's Hospital

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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52936

Identifier Type: -

Identifier Source: org_study_id