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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. Identifier: NCT04209842
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Information provided by (Responsible Party):
Roberto Gugig, Stanford University

Tracking Information
First Submitted Date  ICMJE December 20, 2019
First Posted Date  ICMJE December 24, 2019
Last Update Posted Date December 24, 2019
Estimated Study Start Date  ICMJE March 20, 2020
Estimated Primary Completion Date March 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
change from baseline weight [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effectiveness Gastric Balloon in Obese Adolescents
Official Title  ICMJE Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity, Morbid
Intervention  ICMJE Device: gastric balloon
non surgical weight loss via placement of gastric balloon
Other Name: Orbera
Study Arms  ICMJE Experimental: gastric ballon placement
will receive gastric balloon placed via endoscopy
Intervention: Device: gastric balloon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 20, 2022
Estimated Primary Completion Date March 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04209842
Other Study ID Numbers  ICMJE 52936
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roberto Gugig, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto Gugig, MD Stanford University
Principal Investigator: Monique T Barakat, MD Stanford University
PRS Account Stanford University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP