Trial Outcomes & Findings for Intragastric Balloon in Obese Adolescents With Comorbidities (NCT NCT03233048)
NCT ID: NCT03233048
Last Updated: 2022-05-03
Results Overview
Weight loss will be measured by change in weight divided by baseline weight.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
up to 1 year
Results posted on
2022-05-03
Participant Flow
Participant milestones
| Measure |
ORBERA™ Intragastric Balloon
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
ORBERA™ Intragastric Balloon
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Intragastric Balloon in Obese Adolescents With Comorbidities
Baseline characteristics by cohort
| Measure |
ORBERA™ Intragastric Balloon
n=5 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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Age, Continuous
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16 years
STANDARD_DEVIATION 0.7 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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3 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
White
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4 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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1 Participants
n=99 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
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Region of Enrollment
United States
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5 participants
n=99 Participants
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PRIMARY outcome
Timeframe: up to 1 yearWeight loss will be measured by change in weight divided by baseline weight.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss
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2 Participants
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SECONDARY outcome
Timeframe: Baseline, end of study (approximately 1 year)Change will be measured as a percentage by taking change in ALT divided by baseline ALT.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Change in Alanine Aminotransferase (ALT)
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25.7 percentage of change in ALT level
Standard Deviation 36
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SECONDARY outcome
Timeframe: Baseline, end of study (approximately 1 year)Change will be measured as a percentage by taking change in AST divided by baseline AST.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Change in Aspartate Aminotransferase (AST)
|
11.5 percentage of change in AST level
Standard Deviation 12
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SECONDARY outcome
Timeframe: Baseline, end of study (approximately 1 year)Change will be measured as a percentage by taking change in fasting insulin divided by baseline fasting insulin.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Change in Fasting Insulin
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33 percentage of change in insulin level
Standard Deviation 57.5
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SECONDARY outcome
Timeframe: Baseline, end of study (approximately 1 year)Change will be measured as a percentage by taking change in HgA1c divided by baseline HgA1c.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Change in Hemoglobin A1c (HgA1c)
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0.5 percentage of change in HgA1c level
Standard Deviation 0.3
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SECONDARY outcome
Timeframe: Baseline, end of study (approximately 1 year)Change will be measured as a percentage by taking change in HDL divided by baseline HDL.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Change in High-density Lipoprotein (HDL)
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23.4 percentage of change in HDL level
Standard Deviation 31
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SECONDARY outcome
Timeframe: Baseline, end of study (approximately 1 year)Change will be measured as a percentage by taking change in LDL divided by baseline LDL.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Change in Low-density Lipoprotein (LDL)
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9 percentage of change in LDL level
Standard Deviation 19
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SECONDARY outcome
Timeframe: Baseline, end of study (approximately 1 year)Change will be measured as a percentage by taking change in triglycerides divided by baseline triglycerides.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Change in Triglycerides
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28 percentage of change in triglycerides
Standard Deviation 22
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SECONDARY outcome
Timeframe: Intragastric balloon (IGB) removal (approximately 6 months)Number of participants to experience one or more serious adverse events as defined as Grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) scale.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Number of Participants With One or More Serious Adverse Events
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0 Participants
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SECONDARY outcome
Timeframe: Intragastric balloon (IGB) removal (approximately 6 months)Population: At the request of the subject Intragastric balloon (IGB) was removed at 3 months and the subject was withdrawn from the study (withdrawal by subject).
Early will be defined as balloon removal prior to the 6 month window time point as defined in the protocol.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=5 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Number of Subjects Who Had the Balloon Removed Early
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1 Participants
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SECONDARY outcome
Timeframe: Intragastric balloon (IGB) removal (approximately 6 months)Early will be defined as balloon deflation prior to the 6 month window time point as defined in the protocol.
Outcome measures
| Measure |
ORBERA™ Intragastric Balloon
n=4 Participants
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Number of Subjects Whose Balloon Deflated Early
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0 Participants
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Adverse Events
ORBERA™ Intragastric Balloon
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ORBERA™ Intragastric Balloon
n=5 participants at risk
Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.
ORBERA™ Intragastric Balloon: The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
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|---|---|
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Gastrointestinal disorders
Nausea
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60.0%
3/5 • Number of events 3 • Adverse events were collected from baseline to end of study participation for a total of approximately 12 months on all participants
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Gastrointestinal disorders
Abdominal pain/discomfort
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80.0%
4/5 • Number of events 4 • Adverse events were collected from baseline to end of study participation for a total of approximately 12 months on all participants
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Gastrointestinal disorders
Vomiting
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20.0%
1/5 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 12 months on all participants
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place