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Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

NCT06867731 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-05-30

No results posted yet for this study

Summary

The study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. Investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy.

Conditions

  • Liver Fibrosis
  • Cirrhosis

Interventions

PROCEDURE

Endosonographic Elastography

The patient will undergo a standard-of-care endoscopic ultrasound with liver biopsy. At the time, elastography of the liver and spleen will be performed while using the echoendoscope. Different degrees of pressure will be applied while performing elastography of the left and right lobes of the liver as well as the spleen. The E values and VsN values will be recorded and then compared to liver histology.

DIAGNOSTIC_TEST

Endosonographic shear wave elastography

The patient will undergo an upper endoscopic ultrasound procedure. During this procedure, the patient will be put to sleep and a trained endosonographer physician will insert an echo-endoscope through the mouth and guide it down to the stomach and the duodenum. This endoscope is equipped with technology that uses sound waves to assess the stiffness of the liver and spleen. For research purposes, the doctor will also press on these organs in order to take the additional measurements.

Sponsors & Collaborators

  • Fujifilm

    collaborator INDUSTRY

  • Providence Medical Research Center

    lead OTHER

Principal Investigators

  • Divyanshoo R Kohli, MD FACG FASGE · Providence Sacred Heart Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2026-01-30
Completion
2027-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867731 on ClinicalTrials.gov