Back to resultsEffectiveness Gastric Balloon in Obese Adolescents
Primary Purpose
Obesity, Morbid
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gastric balloon
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid
Eligibility 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).
Sites / Locations
- Lucille Packard Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gastric ballon placement
Arm Description
will receive gastric balloon placed via endoscopy
Outcomes
Primary Outcome Measures
change from baseline weight
Secondary Outcome Measures
Full Information
NCT ID
NCT04209842
First Posted
December 20, 2019
Last Updated
November 4, 2022
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT04209842
Brief Title
Effectiveness Gastric Balloon in Obese Adolescents
Official Title
Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gastric ballon placement
Arm Type
Experimental
Arm Description
will receive gastric balloon placed via endoscopy
Intervention Type
Device
Intervention Name(s)
gastric balloon
Other Intervention Name(s)
Orbera
Intervention Description
non surgical weight loss via placement of gastric balloon
Primary Outcome Measure Information:
Title
change from baseline weight
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Gugig, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monique T Barakat, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucille Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness Gastric Balloon in Obese Adolescents
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