Trial Outcomes & Findings for A Study to Evaluate Liver Stiffness With Shear Wave Elastography (NCT NCT05097963)

NCT ID: NCT05097963

Last Updated: 2023-11-30

Results Overview

EUS shear wave elastography accuracy obtained by Elastic modulus measurements automatically calculated and a median of 10 readings is generated. Measured as kilopascals (kPA)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: baseline
• Results posted on: 2023-11-30

Participant Flow

Participant milestones

Measure	EUS Shear Wave Elastography Subjects who underwent EUS for clinical indications. EUS shear wave measurements were gathered and studied to determine diagnostic accuracy when compared to Magnetic Resonance (MR) Elastography. Endoscopic Ultrasound Shear Wave Elastography: Software to determine stiffness of liver for evaluating liver fibrosis.
Overall Study STARTED	63
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Measure	EUS Shear Wave Elastography Subjects who underwent EUS for clinical indications. EUS shear wave measurements were gathered and studied to determine diagnostic accuracy when compared to Magnetic Resonance (MR) Elastography. Endoscopic Ultrasound Shear Wave Elastography: Software to determine stiffness of liver for evaluating liver fibrosis.
Overall Study Protocol Violation	13
Overall Study Withdrawal by Subject	21

Baseline Characteristics

A Study to Evaluate Liver Stiffness With Shear Wave Elastography

Baseline characteristics by cohort

Measure	EUS Shear Wave Elastography n=63 Participants Subjects who underwent EUS for clinical indications. EUS shear wave measurements were gathered and studied to determine diagnostic accuracy when compared to MR Elastography. Endoscopic Ultrasound Shear Wave Elastography: Software to determine stiffness of liver for evaluating liver fibrosis.
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Population: Data was not collected or analyzed for 34 subjects.

EUS shear wave elastography accuracy obtained by Elastic modulus measurements automatically calculated and a median of 10 readings is generated. Measured as kilopascals (kPA)

Outcome measures

Measure	EUS Shear Wave Elastography n=29 Participants Subjects who underwent EUS for clinical indications. EUS shear wave measurements were gathered and studied to determine diagnostic accuracy when compared to MR Elastography. Endoscopic Ultrasound Shear Wave Elastography: Software to determine stiffness of liver for evaluating liver fibrosis.
Median Endoscopic Ultrasound (EUS) Shear Wave Elastography	0.11 kPA Interval 0.05 to 0.17

Adverse Events

EUS Shear Wave Elastography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vinay Chandrasekhara, M.D.

Mayo Clinic

Phone: 507-284-2687

Email: Chandrasekhara.Vinay@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place