Trial Outcomes & Findings for Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically (NCT NCT02248688)
NCT ID: NCT02248688
Last Updated: 2022-01-25
Results Overview
The mean body weight of all 5 participants at 6-Months post-procedure.
COMPLETED
NA
5 participants
6-Month
2022-01-25
Participant Flow
Participant milestones
| Measure |
BeadBlock 300 - 500 Micron Will be Used as the Embolic Agent to Embolize Left Gastric Artery.
Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
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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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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measure taken for diabetic participant.
Baseline characteristics by cohort
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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5 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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5 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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5 participants
n=5 Participants
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Weight
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242.2 Pounds
n=5 Participants
|
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BMI
|
42.42 kg/m^2
n=5 Participants
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Cholecystokinin
|
55.8 pg/mL
n=5 Participants
|
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Ghrelin
|
794 pg/mL
n=5 Participants
|
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Leptin
|
30.0 ng/mL
n=5 Participants
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Hemoglobin-A1c (HgA1c)
|
7.4 Percentage of HgA1c
n=1 Participants • Measure taken for diabetic participant.
|
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Urine Pregnancy Test (only if female of child-bearing potential)
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0 Number of Participants
n=4 Participants • Measure only taken for female participants. A participant who is pregnant (i.e., has a positive urine pregnancy test) will be scored as a "1". A participant who is not pregnant (i.e., has a negative urine pregnancy test) will be scored as a "0".
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Complete blood count (CBC)
Normal
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5 Participants
n=5 Participants
|
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Complete blood count (CBC)
Abnormal
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0 Participants
n=5 Participants
|
|
Blood Urea Nitrogen (BUN)/Creatinine
Normal
|
5 Participants
n=5 Participants
|
|
Blood Urea Nitrogen (BUN)/Creatinine
Abnormal
|
0 Participants
n=5 Participants
|
|
Prothrombin Time/Partial Thromboplastin Time (PT/PTT)
Normal
|
5 Participants
n=5 Participants
|
|
Prothrombin Time/Partial Thromboplastin Time (PT/PTT)
Abnormal
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0 Participants
n=5 Participants
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Computed Tomography (CT) Angiogram
Normal
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4 Participants
n=5 Participants
|
|
Computed Tomography (CT) Angiogram
Abnormal
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1 Participants
n=5 Participants
|
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Upper Endoscopy
Normal
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5 Participants
n=5 Participants
|
|
Upper Endoscopy
Abnormal
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0 Participants
n=5 Participants
|
|
Stool Guaiac
Normal
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5 Participants
n=5 Participants
|
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Stool Guaiac
Abnormal
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0 Participants
n=5 Participants
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Nuclear Medicine: Gastric Emptying Study
Normal
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5 Participants
n=5 Participants
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Nuclear Medicine: Gastric Emptying Study
Abnormal
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0 Participants
n=5 Participants
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Short Form (SF)-36v2 Questionnaire, Physical Component Summary (PCS)
|
49.8 Scores on a Scale
n=5 Participants
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Short Form (SF)-36 Version 2 Questionnaire Mental Component Summary (MCS)
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48.2 Scores on a Scale
n=5 Participants
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PRIMARY outcome
Timeframe: 6-MonthThe mean body weight of all 5 participants at 6-Months post-procedure.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
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|---|---|
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Body Weight Average 6 Months Post-Procedure
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237.6 lbs.
Interval 161.0 to 268.0
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PRIMARY outcome
Timeframe: 12-MonthThe mean body weight of all 5 participants at 12-Months post-procedure.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Body Weight Average 12 Months Post-Procedure
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238 lbs.
Interval 151.0 to 272.0
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PRIMARY outcome
Timeframe: Baseline, 6 MonthsAverage change in body weight lost. Calculated as the average of participants: (6-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Change in Average Body Weight From Baseline at 6 Months Post-Procedure
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16.6 lbs
Interval 2.0 to 38.0
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PRIMARY outcome
Timeframe: Baseline, 12 MonthsAverage change in body weight lost. Calculated as the average of participants: (12-Month Post-Procedure Weight in lbs.) - (Baseline Weight in lbs.)
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Change in Average Body Weight From Baseline at 12 Months Post-Procedure
|
-16.2 lbs
Interval -48.0 to 0.0
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PRIMARY outcome
Timeframe: Baseline, 6 MonthCalculated as the average of participants: (((Baseline Weight in lbs.) - (6 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
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Percentage of Excess Body Weight Loss at 6 Months Post-Procedure
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14.8 Percentage of Excess Body Weight Loss
Interval 1.8 to 40.4
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PRIMARY outcome
Timeframe: Baseline, 12 MonthCalculated as the average of participants: (((Baseline Weight in lbs.) - (12 Month Post-Procedure Weigh in lbs.))/((Baseline Weight in lbs.) - (Ideal Body Weight in lbs.)))
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
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|---|---|
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Percentage of Excess Body Weight Loss at 12 Months Post-Procedure
|
15.1 Percentage of Excess Body Weight Loss
Interval 0.0 to 51.1
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PRIMARY outcome
Timeframe: 6-MonthThe mean of participant's 6-Month post-procedure Ghrelin levels.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
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|---|---|
|
Average Ghrelin Hormone Levels at 6 Months Post-Procedure
|
605.4 pg/mL
Interval 331.0 to 1084.0
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PRIMARY outcome
Timeframe: 12-MonthThe mean of participant's 12-Month post-procedure Ghrelin levels.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
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|---|---|
|
Average Ghrelin Hormone Levels at 12 Months Post-Procedure
|
21.1 pg/mL
Interval 4.0 to 39.0
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PRIMARY outcome
Timeframe: 6-Month, BaselineCalculated as the average of participants: (((6-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) \* 100
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
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|---|---|
|
Percentage Change in Ghrelin Hormone Levels From Baseline at 6 Months Post-Procedure
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-9.9 Percentage of Change in Ghrelin
Interval -70.7 to 39.1
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PRIMARY outcome
Timeframe: 12-Month, BaselineCalculated as the average of participants: (((12-Month Post-Procedure Ghrelin levels in pg/mL) - (Baseline Ghrelin levels in pg/mL))/(Baseline Ghrelin levels in pg/mL) \* 100
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Percentage Change in Ghrelin Hormone Levels From Baseline at 12 Months Post-Procedure
|
-19.2 Percentage of Change in Ghrelin
Interval -63.6 to 35.9
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SECONDARY outcome
Timeframe: 6-MonthThe mean of participant's 6-month post-procedure Leptin levels.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Average Leptin Hormone Levels at 6 Months Post-Procedure
|
19.4 ng/mL
Interval 7.0 to 46.8
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SECONDARY outcome
Timeframe: 12-MonthThe mean of participant's 12-month post-procedure Leptin levels.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Average Leptin Hormone Levels at 12 Months Post-Procedure
|
21.1 ng/mL
Interval 4.0 to 39.0
|
SECONDARY outcome
Timeframe: 6-Month, BaselineCalculated as the average of participants: (((6-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) \* 100
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Percentage Change in Leptin Hormone Levels From Baseline at 6 Months Post-Procedure
|
-31.2 Percentage of Change in Leptin
Interval -69.2 to 75.3
|
SECONDARY outcome
Timeframe: 12-Month, BaselineCalculated as the average of participants: (((12-Month Post-Procedure Leptin levels in ng/mL) - (Baseline Leptin levels in ng/mL))/(Baseline Leptin levels in ng/mL) \* 100
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Percentage Change in Leptin Hormone Levels From Baseline at 12 Months Post-Procedure
|
21.1 Percentage of Change in Leptin
Interval 4.0 to 39.0
|
SECONDARY outcome
Timeframe: 6-MonthThe mean of participant's 6-month post-procedure CCK levels.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Average Cholecystokinin (CCK) Hormone Levels at 6 Months Post-Procedure
|
32.4 pg/mL
Interval 15.0 to 76.0
|
SECONDARY outcome
Timeframe: 12-MonthThe mean of participant's 12-month post-procedure CCK levels.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Average Cholecystokinin (CCK) Hormone Levels at 12 Months Post-Procedure
|
44.6 pg/mL
Interval 15.0 to 73.0
|
SECONDARY outcome
Timeframe: 6-Month, BaselineCalculated as the average of participants: (((6-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) \* 100
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 6 Months Post-Procedure
|
-15.1 Percentage of Change in CCK
Interval -70.3 to 100.0
|
SECONDARY outcome
Timeframe: 12-Month, BaselineCalculated as the average of participants: (((12-Month Post-Procedure CCK levels in pg/mL) - (Baseline CCK levels in pg/mL))/(Baseline CCK levels in pg/mL) \* 100
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Percentage Change in Cholecystokinin (CCK) Hormone Levels From Baseline at 12 Months Post-Procedure
|
56.4 Percentage of Change in CCK
Interval -47.0 to 430.0
|
SECONDARY outcome
Timeframe: 6 MonthThe mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Quality of Life (QOL): Averaged Short Form (SF)-36 Version 2 Physical Component Summary (PCS) at 6 Months Post-Procedure
|
59.5 Scores on a Scale
Interval 41.0 to 93.8
|
SECONDARY outcome
Timeframe: 6 Month, BaselineThe mean of participant's SF-36 Version 2 PCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 6 Months Post-Procedure
|
9.7 Scores on a Scale
Interval 3.2 to 14.0
|
SECONDARY outcome
Timeframe: 12 MonthThe mean of participant's 12-month post-procedure Short Form-36 Version 2 Physical Component Scores, ranging from 0-100; higher scores indicate better health status.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
QOL: Averaged SF-36v2 PCS at 12 Months Post-Procedure
|
65.79 Scores on a Scale
Interval 40.2 to 95.0
|
SECONDARY outcome
Timeframe: 12 Month, BaselineThe mean of participant's SF-36 Version 2 PCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the PCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 PCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 PCS) - (Baseline SF-36v2 PCS)
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Changes in QOL (Measured by SF-36v2 PCS) From Baseline at 12 Months Post-Procedure
|
16.0 Scores on a Scale
Interval 2.4 to 59.0
|
SECONDARY outcome
Timeframe: 6 MonthThe mean of participant's SF-36 Version 2 MCS at 6-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
QOL: Averaged SF-36v2 MCS at 6 Months Post-Procedure
|
57 Scores on a Scale
Interval 41.8 to 88.4
|
SECONDARY outcome
Timeframe: 6 Month, BaselineThe mean of participant's SF-36 Version 2 MCS at 6 months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (6-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 6 Months Post-Procedure
|
8.9 Scores on a Scale
Interval -1.2 to 20.5
|
SECONDARY outcome
Timeframe: 12 MonthThe mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
QOL: Averaged SF-36v2 MCS at 12 Months Post-Procedure
|
63.1 Scores on a Scale
Interval 36.3 to 88.75
|
SECONDARY outcome
Timeframe: 12 Month, BaselineThe mean of participant's SF-36 Version 2 MCS at 12-months post-procedure, ranging from 0-100; higher scores indicate better health status. The SF-36v2 contains 8 sections total which are each calculated into individual scale scores. A z-score is then determined for each scale score by subtracting the mean scale score of a sample of the national general population from the scale score of the individual participant being analyzed. Each of the 8 z-scores are then multiplied by the MCS scoring coefficient, added together, multiplied by 10 and added to 50. Changes in QOL (measured by SF-36v2 MCS) are calculated as the average of participants: (12-Month Post-Procedure SF-36v2 MCS) - (Baseline SF-36v2 MCS)
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=5 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Changes in QOL (Measured by SF-36v2 MCS) From Baseline at 12 Months Post-Procedure
|
14.9 Scores on a Scale
Interval -6.7 to 48.3
|
SECONDARY outcome
Timeframe: 6-MonthPopulation: Applies to the sole diabetic patient in the trial.
HgA1c Levels of diabetic patient 6-Months post-procedure.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=1 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
6-Month Post-Procedure Hemoglobin-A1c (HgA1c) Levels
|
6.3 Percentage of HgA1c
|
SECONDARY outcome
Timeframe: 12-MonthPopulation: Applies to the sole diabetic patient in the trial.
HgA1c Levels of diabetic patient 12-Months post-procedure.
Outcome measures
| Measure |
Embolic Agent - BeadBlock
n=1 Participants
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
12-Month Post-Procedure HgA1c Levels
|
5.9 Percentage of HgA1c
|
Adverse Events
Embolic Agent - BeadBlock
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Embolic Agent - BeadBlock
n=5 participants at risk
Left Gastric Artery Embolization - Embolic Agent - BeadBlock 300 - 500 Micron will be used as the embolic agent to embolize left gastric artery.
BeadBlock 300 - 500 Micron: Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Left Gastric Artery Embolization
|
|---|---|
|
Gastrointestinal disorders
Mild Nausea, Vomiting
|
20.0%
1/5 • Number of events 1 • 12 Months
|
Additional Information
Mubin Syed, MD
Dayton Interventional Radiology-Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place