Liver FibrosesNCT03047707
S-Shearwave Elastography for Assessment of Hepatic Fibrosis
A study testing S-Shearwave and TE in people with Liver Fibroses, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Fibroses
- What is being tested?
- S-Shearwave and TE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
- Signed informed consent
Who cannot join
- Acute hepatitis or bile duct obstruction
- Serum ALT> 5 times the upper limit of normal within 3 months
- s/p Rt. hemihepatectomy
- s/p liver transplantation
- Large mass or infiltrative lesion in the right lobe of the liver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study
The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.
- Conditions
- Liver Fibroses
- Being tested
- S-Shearwave and TE
- Keywords
- ultrasound elastography, S-Shearwave, liver, fibrosis
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Shearwave and TEDiagnostic test
S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.
| Study group | Role | What they receive |
|---|---|---|
| S-Shearwave and TE | Experimental | Not described Receives: Diagnostic Test: S-Shearwave and TE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance to detect severe hepatic fibrosis (F3)
Reference standard: histologic diagnosis or Transient elastography
Measured: 3 months
Secondary outcomes (5)
Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes
Measured: 3 months
Intra-observer and inter-observer agreement of S-Shearwave measurements
Measured: same day
Comparison of diagnostic performance: Shearwave vs. Transient elastography
Reference standard: histologic diagnosis
Measured: 3 months
Usefulness of auto-profile function in S-Shearwave measurements
Measured: 3 months
Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start22 May 2017
- Primary completion24 Apr 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medison
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047707
- Sponsor's protocol ID
- SNUH-2017-0215
- Status last verified
- Jun 2018
- First submitted
- 8 Feb 2017
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03047707
- Acronym / sponsor ID
- SNUH-2017-0215
- Conditions
- Liver Fibroses
- Keywords
- ultrasound elastography, S-Shearwave, liver, fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medison
- Study start
- 22 May 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-Shearwave and TE | Experimental | Diagnostic Test: S-Shearwave and TE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
- Signed informed consent
Key exclusion criteria (5 listed)
- Acute hepatitis or bile duct obstruction
- Serum ALT> 5 times the upper limit of normal within 3 months
- s/p Rt. hemihepatectomy
- s/p liver transplantation
- Large mass or infiltrative lesion in the right lobe of the liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-Shearwave and TES-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness. | Diagnostic test | S-Shearwave and TE |
Primary outcome
Diagnostic performance to detect severe hepatic fibrosis (F3)
Time frame: 3 months
Reference standard: histologic diagnosis or Transient elastography
5 secondary outcomes
Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes
Time frame: 3 months
Intra-observer and inter-observer agreement of S-Shearwave measurements
Time frame: same day
Comparison of diagnostic performance: Shearwave vs. Transient elastography
Time frame: 3 months
Usefulness of auto-profile function in S-Shearwave measurements
Time frame: 3 months
Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Min Lee, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-Shearwave and TE in people with Liver Fibroses, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance to detect severe hepatic fibrosis (F3) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.