SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases (SWE Predict)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03389152 |
Recruitment Status :
Completed
First Posted : January 3, 2018
Last Update Posted : July 27, 2020
|
Sponsor:
SuperSonic Imagine
Collaborator:
University of Bonn
Information provided by (Responsible Party):
SuperSonic Imagine
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease.
Condition or disease | Intervention/treatment |
---|---|
Liver Fibroses | Device: Elastography |
Study Type : | Observational |
Actual Enrollment : | 2148 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Evaluation of SWE as a Predictive Tool for Progression of Chronic Liver Diseases |
Actual Study Start Date : | July 26, 2007 |
Actual Primary Completion Date : | January 9, 2018 |
Actual Study Completion Date : | November 28, 2019 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
North American Indian childhood cirrhosis
MedlinePlus related topics:
Liver Diseases
Intervention Details:
- Device: Elastography
liver stiffness measurements by shear wave-based elastography
Primary Outcome Measures :
- Liver disease progression rate [ Time Frame: Minimum of 28 days follow-up ]Clinical signs of liver decompensation
- Mortality rate [ Time Frame: Minimum of 28 days follow-up ]Patient's death
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study Population
Patients with suspected or confirmed chronic liver disease of viral and/or steatotic origin, requiring a percutaneous liver biopsy, and who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease.
Criteria
Inclusion Criteria:
- Patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin,
- Patients who had reached the age of majority in their countries, at baseline,
- Patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis),
- Patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded
Exclusion Criteria:
- Cause of chronic liver disease other than viral, ALD or NAFLD ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...)
- Any systemic, viral hepatitis and HIV co-infection
No Contacts or Locations Provided
Publications:
Responsible Party: | SuperSonic Imagine |
ClinicalTrials.gov Identifier: | NCT03389152 |
Other Study ID Numbers: |
LE3 |
First Posted: | January 3, 2018 Key Record Dates |
Last Update Posted: | July 27, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | At the end of the study, sharing of IPD will not be required. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
Liver Diseases Liver Cirrhosis Fibrosis Pathologic Processes Digestive System Diseases |