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The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis

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: NCT03957070
Recruitment Status : Completed
First Posted : May 21, 2019
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sonic Incytes

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date November 8, 2021
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)		 Discrimination of healthy from patients with liver fibrosis [ Time Frame: 6 months ]
The discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements. An receiver operating characteristic (ROC) curve using final Liver Incyte elasticity measurement as a predictor of healthy versus fibrotic (HCV/NASH) will be constructed with accompanying 95% confidence interval for the area under the curve (AUC). The AUC and 95% confidence intervals for the FibroScan device will be calculated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)		 Safety of the device as measured by rate of adverse events [ Time Frame: 6 months ]
The safety and tolerability of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis Rate of adverse events when using the investigational device will be reported.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 16, 2019)
  • Agreement between Liver Incytes and MRI elastography measurements [ Time Frame: 6 months ]
    Elasticity measurements from Liver Incyte and MRE will be compared using a concordance correlation coefficient and associated 95% confidence intervals. A Spearman correlation coefficient and 95% confidence intervals will also be calculated. As in the analysis for the Primary Objective, an ROC curve will be constructed and AUCs for differentiating healthy versus fibrotic (HVC/NASH) will be calculated.
  • Correlation between Liver Incytes and MRI elastography measurements [ Time Frame: 6 months ]
    Steatosis measurements from Liver Incyte, Fibroscan (CAP), and MRI (PDFF) will be compared using a concordance correlation coefficient and associated 95% confidence intervals. A Spearman correlation coefficient and 95% confidence intervals will also be calculated. An ROC curve will be constructed and AUCs for differentiating healthy versus fibrotic (HCV/NASH) will be calculated.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Official Title  ICMJE The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Brief Summary Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.
Detailed Description

This will be a prospective, open label, feasibility and validation study of the Liver Incyte system in patients with liver fibrosis (Cohort 1, n = 150) and healthy volunteers (Cohort 2, n = 50), for a total of 200 participants. The physician operator of the FibroScan, and the operator of the Shear wave vibro-elastography (S-WAVE) system, will not be blinded to the clinical diagnoses of the patients. All patients will undergo the testing with both FibroScan and Liver Incyte system at a single in-clinic visit.

The liver stiffness of each participant will be assessed with the Liver Incyte Model B device and with FibroScan. The elasticity measurements from these two devices will be the primary outcome measure.

The Liver Incyte system is designed as two models with differences in the ultrasound components only, description of the two models is below. Two sub-studies are included in this design as exploratory objectives. Model B will be utilized at all study sites and all study participants. Participants at the LAIR study site will also be evaluated using Model A, as well as Model B, for verification and to confirm consistency between designs. Participants will have the option to participate in the Magnetic Resonance Elastography (MRE) and Proton Density Fat Fraction (PDFF) portion of the study. MRE/PDFF is an optional procedure, which makes up a sub-study for this trial, this would require approximately 1 hour, and is open to any participant who is willing and has time for the extra study visit. The results of the MRE/PDFF sub-study will be included as an exploratory objective.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Liver Fibrosis
  • Liver Steatosis
Intervention  ICMJE Device: Liver Incyte
Ultrasound elasticity imaging
Study Arms  ICMJE Experimental: Liver Incyte
Patients with successfully treated HCV, or NASH Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte.
Intervention: Device: Liver Incyte
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2021)		 140
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019)		 200
Actual Study Completion Date  ICMJE April 1, 2021
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Any sex, ages 19-75 years inclusively
  • Individuals with a history of chronic Hepatitis C (HCV) or non-alcoholic steatohepatitis (NASH). Patients with history of Hepatitis C must have completed treatment and achieved Sustained viral response at 12 weeks (SVR12).
  • Previous FibroScan measurement (within the last 13 months) between 8 kilopascals and 35 kilopascals.
  • Able to understand the informed consent form, study procedures and willing to participate in study

Exclusion Criteria:

  • Unable to achieve SVR12 with previous antiviral treatment for HCV
  • Multiple (>1) liver disease diagnoses within the past 12 months
  • Co-infection with another Hepatitis virus or Human Immunodeficiency Virus (HIV), last testing within past 5 years
  • Documented or known ascites
  • Documented or known portal hypertension
  • BMI greater than 35 kg/m2 (30 kg/m2 for optional MRE participants)
  • If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
  • Individuals with history of persistent ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average [1 standard drink = 10 grams of alcohol])
  • Individuals with implanted electrical devices such as pacemakers, internal defibrillators, cochlear implants and nerve stimulators.
  • Individuals with surgically removed gallbladder (for optional MRE procedure only)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957070
Other Study ID Numbers  ICMJE SI-CLIN-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sonic Incytes
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sonic Incytes
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sonic Incytes
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP