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Effectiveness Gastric Balloon in Obese Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209842
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto Gugig, Stanford University

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Device: gastric balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support
Estimated Study Start Date : March 20, 2020
Estimated Primary Completion Date : March 20, 2022
Estimated Study Completion Date : March 20, 2022

Arm Intervention/treatment
Experimental: gastric ballon placement
will receive gastric balloon placed via endoscopy
Device: gastric balloon
non surgical weight loss via placement of gastric balloon
Other Name: Orbera




Primary Outcome Measures :
  1. change from baseline weight [ Time Frame: 6 months ]


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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209842


Locations
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United States, California
Lucille Packard Children's Hospital
Palo Alto, California, United States, 94305
Contact: Roberto Gugig, MD       rgugig@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Roberto Gugig, MD Stanford University
Principal Investigator: Monique T Barakat, MD Stanford University
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Responsible Party: Roberto Gugig, professor of pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT04209842    
Other Study ID Numbers: 52936
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms