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Elastography Device

Liver Incytes System for Non-alcoholic Fatty Liver Disease

N/A

Waitlist Available

Research Sponsored by Sonic Incytes

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trialcompares different non-invasive techniques to measure stiffness in the liver, to find the most effective way.

Eligible Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)
Liver Fibrosis
Non-alcoholic Fatty Liver Disease
Fatty Liver

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of Liver Incytes' discriminatory ability of liver stiffness as measured by fibrosis staging

Elasticity measurements comparison between Liver Incytes MR Elastography

Secondary outcome measures

Liver extract

Comparison between Liver Incytes' and FibroScan's fibrosis staging capabilities

Comparison between Liver Incytes' and FibroScan's steatosis staging capabilities

+2 more

Other outcome measures

Identification of cases in which FibroScan may overestimate or underestimate fat content

Identification of cases in which FibroScan may overestimate or underestimate liver stiffness

Liver extract

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-labelExperimental Treatment1 Intervention

Volunteers who have agreed to participate in the study will have their liver scanned using the FibroScan, VE (Liver Incytes System) and MRE techniques.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Sonic IncytesLead Sponsor

5 Previous Clinical Trials

546 Total Patients Enrolled

3 Trials studying Non-alcoholic Fatty Liver Disease

336 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is senior-aged individuals being accepted into this clinical trial?

"Per the trial's criteria for eligibility, individuals must be between 19 and 75 years of age to qualify."

Answered by AI

Is enrollment still ongoing for this experiment?

"At present, clinicaltrials.gov does not list this study as actively recruiting participants. Initially posted on October 21st 2020, the listing was last updated December 7th 2022. Despite being closed for recruitment at this time, there are currently 773 other trials open to patient enrollment."

Answered by AI

What is the primary purpose of this clinical experiment?

"According to Sonic Incytes, the principal aim of this 12-month clinical trial is assessing Liver Incytes' diagnostic ability in regards to fibrosis staging. Furthermore, secondary objectives include ascertaining the occurrence and technical issues with devices; establishing whether attenuation measurements from MRI Proton Density Fat Fraction and Liver Incytes System are comparable using a concordance correlation coefficient and 95% confidence intervals; as well as comparing FibroScan's elasticity (kPa) readings with those collected by Liver Incyte’s system against Magnetic Resonance Elastography (MRE) results for constructing Receiver Operating Curves"

Answered by AI

Is there a possibility of my participation in this clinical research?

"For this research study, volunteers need to be between 19 and 75 years old with a diagnosis of fibrosis. A total of 164 participants are being recruited for the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF

2020. "The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04682600.