Trial Outcomes & Findings for Conditionally Increased Output (CIO) Enhanced Ultrasound System (NCT NCT05792423)
NCT ID: NCT05792423
Last Updated: 2025-05-23
Results Overview
AST value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Pre-ultrasound imaging and 7 day after the ultrasound imaging (within 2 weeks timeframe)
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Evaluation of Liver Stiffness Using Conditionally Increased Output (CIO) Enhanced Ultrasound System
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Evaluation of Liver Stiffness Using Conditionally Increased Output (CIO) Enhanced Ultrasound System
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Conditionally Increased Output (CIO) Enhanced Ultrasound System
Baseline characteristics by cohort
| Measure |
Evaluation of Liver Stiffness Using Conditionally Increased Output (CIO) Enhanced Ultrasound System
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
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|---|---|
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Age, Continuous
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39.6 years
STANDARD_DEVIATION 16.3 • n=5 Participants
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 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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3 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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2 Participants
n=5 Participants
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Race (NIH/OMB)
White
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13 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
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|
Region of Enrollment
United States
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22 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Pre-ultrasound imaging and 7 day after the ultrasound imaging (within 2 weeks timeframe)AST value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
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|---|---|
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Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day7 Post-imaging
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-0.5 international units per liter
Interval -2.5 to 1.5
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PRIMARY outcome
Timeframe: Pre-ultrasound imaging and 7 day after the ultrasound imaging (within 2 weeks timeframe)ALT value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
|
|---|---|
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Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day7 Post-imaging
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-0.3 international units per liter
Interval -2.6 to 2.1
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PRIMARY outcome
Timeframe: Pre-ultrasound imaging and 7 day after the ultrasound imaging (within 2 weeks timeframe)ALP value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
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|---|---|
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Mean Difference in Alkaline Phosphatase (ALP) Value in U/L Unit Between Pre-imaging and day7 Post-imaging
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2.2 international units per liter
Interval -0.6 to 5.0
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SECONDARY outcome
Timeframe: Single visit (1day)IQR/median is a commonly accepted variability analysis tool for SWE. We are hoping to understand the variability difference between these two ultrasound modes in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
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|---|---|
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Mean Difference in IQR/Median Ratio Between Standard and CIO SWE
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-0.019 No Unit of Measure
Interval -0.034 to -0.005
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SECONDARY outcome
Timeframe: Pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)AST value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
|
|---|---|
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Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day1 Post-imaging
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-0.9 international units per liter
Interval -2.3 to 0.6
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SECONDARY outcome
Timeframe: Pre-ultrasound imaging and 2 day after the ultrasound imaging (within 2 weeks timeframe)AST value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
|
|---|---|
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Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day2 Post-imaging
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-1.0 international units per liter
Interval -2.4 to 0.3
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SECONDARY outcome
Timeframe: Pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)ALT value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
|
|---|---|
|
Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day1 Post-imaging
|
0.3 international units per liter
Interval -1.0 to 1.7
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SECONDARY outcome
Timeframe: Pre-ultrasound imaging and 2 day after the ultrasound imaging (within 2 weeks timeframe)ALT value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
|
|---|---|
|
Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day2 Post-imaging
|
-0.6 international units per liter
Interval -2.5 to 1.3
|
SECONDARY outcome
Timeframe: Pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)ALP value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
|
|---|---|
|
Mean Difference in Alkaline Phosphatase (ALP) Value in U/L Unit Between Pre-imaging and day1 Post-imaging
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1.7 international units per liter
Interval -1.0 to 4.5
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SECONDARY outcome
Timeframe: Pre-ultrasound imaging and 2 day after the ultrasound imaging (within 2 weeks timeframe)ALP value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.
Outcome measures
| Measure |
24 Healthy Adult Volunteers
n=22 Participants
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
|
|---|---|
|
Mean Difference in Alkaline Phosphatase (ALP) Value in U/L Unit Between Pre-imaging and day2 Post-imaging
|
1.3 international units per liter
Interval -0.6 to 3.2
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Adverse Events
24 Healthy Adult Volunteers
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
24 Healthy Adult Volunteers
n=24 participants at risk
GE ultrasound system with increased acoustic output settings: We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.
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|---|---|
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Investigations
Tingling Sensation
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4.2%
1/24 • Number of events 1 • 6 months
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Investigations
Awareness of Pulse
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4.2%
1/24 • Number of events 1 • 6 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place