Trial Outcomes & Findings for Evaluate Patients With Chronic Hepatitis by Three-dimensional Force-controlled Ultrasound Measurement (NCT NCT02784925)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

up to 6 months

Results posted on

2017-06-22

Participant milestones
Measure	Fatty Liver Subjects Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Evaluate Patients With Chronic Hepatitis by Three-dimensional Force-controlled Ultrasound Measurement

Baseline characteristics by cohort
Measure	Fatty Liver Subjects n=30 Participants Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

Timeframe: up to 6 months

Population: fatty liver patients

Outcome measures
Measure	Fatty Liver Subjects n=30 Participants Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Subcutaneous Fat in Steatosis Patients female__abdomen	9.54 cm^3 Interval 6.79 to 13.98
Subcutaneous Fat in Steatosis Patients male__abdomen	10.48 cm^3 Interval 4.65 to 16.81
Subcutaneous Fat in Steatosis Patients female__front thigh	5.24 cm^3 Interval 3.34 to 11.6
Subcutaneous Fat in Steatosis Patients male__front thigh	4.09 cm^3 Interval 1.89 to 9.12

Serious events: 30 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events
Measure	Fatty Liver Subjects n=30 participants at risk Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Hepatobiliary disorders fatty liver	100.0% 30/30 • Number of events 30

Other adverse events
Measure	Fatty Liver Subjects n=30 participants at risk Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
Social circumstances refuse to have body measurement	100.0% 30/30 • Number of events 30

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