NCT03637959

Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

Detailed description

Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. Participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.

Conditions

• Liver Fibrosis

Interventions

Type	Name	Description
DEVICE	Mechanical Vibrations with Ultrasound Shear Wave Imaging	Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination.

Timeline

• Start date: 2017-01-26
• Primary completion: 2020-11-04
• Completion: 2020-11-04
• First posted: 2018-08-20
• Last updated: 2021-12-13
• Results posted: 2021-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study