Study NCT03957070
The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Submitted Date:  April 13, 2023 (v7)
Quality Control Review Has Not Concluded

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Open or close this module Study Identification
Unique Protocol ID: SI-CLIN-01
Brief Title: The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Official Title: The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2023
Overall Status: Completed
Study Start: February 1, 2019
Primary Completion: April 1, 2021 [Actual]
Study Completion: April 1, 2021 [Actual]
First Submitted: April 3, 2019
First Submitted that
Met QC Criteria:		 May 16, 2019
First Posted: May 21, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: May 9, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sonic Incytes
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Liver Fibrosis
Liver Steatosis
Keywords: liver
ultrasound elastography
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 140 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Liver Incyte with patients with successfully treated HCV, or NAFLD/NASH
Patients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte.
 Device: Liver Incyte
Ultrasound elasticity imaging
Active Comparator: Liver Incyte with healthy volunteers with no history of liver disease.
Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte.
 Device: Liver Incyte
Ultrasound elasticity imaging
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Discrimination of Healthy Volunteers 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.
Secondary Outcome Measures:
1. 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

Total number of adverse events when using the investigational device will be reported.
Other Outcome Measures:
1. Agreement Between Liver Incytes and MRI Elastography Measurements
[ Time Frame: 6 months ]

Elasticity measurements from Liver Incyte and Magnetic Resonant Elastography 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.
Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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)
Open or close this module Contacts/Locations
Locations: United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Canada, British Columbia
LAIR
Vancouver, British Columbia, Canada, V5Z 1H2
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol and Statistical Analysis Plan
Document Date: March 25, 2019
Uploaded: 04/10/2023 18:08
File Name: Prot_SAP_000.pdf
Informed Consent Form
Document Date: January 8, 2019
Uploaded: 04/10/2023 18:05
File Name: ICF_001.pdf

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Document Type or Document Date appear inconsistent with information in an uploaded study document.
  2. Required information appears to be missing.
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details
 
Arm/Group Title Liver Incyte With Patients With Successfully Treated HCV, or NAFLD/NASH Liver Incyte With Healthy Volunteers With no History of Liver Disease.
Arm/Group Description

Patients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging

Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging
Period Title: Overall Study
Started 86 54
Completed 86 54
Not Completed 0 0
Open or close this module Baseline Characteristics
Arm/Group TitleLiver Incyte With Patients With Successfully Treated HCV, or NAFLD/NASHLiver Incyte With Healthy Volunteers With no History of Liver Disease.Total
Arm/Group Description

Patients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging

Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging

Total of all reporting groups
Overall Number of Baseline Participants 86 54 140
Baseline Analysis Population Description [Not Specified]
Age, Continuous
Mean (Full Range)
Unit of measure: years
Number Analyzed86 Participants54 Participants140 Participants
59(31 to 75)28(19 to 61)47.5(19 to 75)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed86 Participants54 Participants140 Participants
Female
32
37.21%
38
70.37%
70
50%
Male
54
62.79%
16
29.63%
70
50%
Race and Ethnicity Not Collected [1]
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed86 Participants54 Participants140 Participants
0
 
[1]Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed86 Participants54 Participants140 Participants
Canada
185472
United States
68068
Liver Incyte Elasticity [1]
Mean (Standard Deviation)
Unit of measure: kilopascals (kPa)
Number Analyzed86 Participants54 Participants140 Participants
6.8(2.69)4.9(0.81)6.1(2.37)
 
[1]Measure Description: The measure of liver stiffness (Elasticity) in pKa
Open or close this module Outcome Measures
1. Primary Outcome:
Title Discrimination of Healthy Volunteers From Patients With Liver Fibrosis
Description

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.

Time Frame 6 months
Outcome Measure Data
Analysis Population Description
All patients and volunteers with complete set of data from Liver Incytes was included in the analysis.
 
Arm/Group TitleLiver Incyte in Healthy Volunteers and Patients With Successfully Treated HCV, or NAFLD/NASH
Arm/Group Description

Patients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging

Overall Number of Participants Analyzed133
Number (95% Confidence Interval)
Unit of Measure: AUROC
0.9379(0.8805 to 0.9636)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Unit of Measure appears invalid.
2. Secondary Outcome:
Title Safety of the Device as Measured by Rate of Adverse Events
Description

The safety and tolerability of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis

Total number of adverse events when using the investigational device will be reported.

Time Frame 6 months
Outcome Measure Data
Analysis Population Description
Patients with adverse events due to scan with Liver Incytes, or the number of patients who stopped the exam due to tolerability issues.
 
Arm/Group TitleLiver Incyte in Healthy Volunteers and Patients With Successfully Treated HCV, or NAFLD/NASH
Arm/Group Description

Patients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging

Overall Number of Participants Analyzed140
Measure Type: Count of Participants
Unit of Measure: Participants
0
0%

Quality Control Review Comment provided by the National Library of Medicine:

  1. The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
3. Other Pre-specified Outcome:
Title Agreement Between Liver Incytes and MRI Elastography Measurements
Description Elasticity measurements from Liver Incyte and Magnetic Resonant Elastography 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.
Time Frame 6 months
Outcome Measure Data Not Reported
Open or close this module Adverse Events
 
Time Frame during duration of participation in study.
Adverse Event Reporting Description All patients were asked to report any adverse events during the duration of the liver scan and participation in the study. No patient was at risk for adverse event from the liver scan. No patient was at risk for mortality during the duration of the study.

Quality Control Review Comment provided by the National Library of Medicine:

  1. There does not appear to be sufficient information to understand the Time Frame.
  2. A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format.
 
Arm/Group Title Liver Incyte With Patients With Successfully Treated HCV, or NAFLD/NASH Liver Incyte With Healthy Volunteers With no History of Liver Disease.
Arm/Group Description

Patients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging

Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Liver Incyte: Ultrasound elasticity imaging
All-Cause Mortality
  Liver Incyte With Patients With Successfully Treated HCV, or NAFLD/NASHLiver Incyte With Healthy Volunteers With no History of Liver Disease.
 Affected / At Risk (%)Affected / At Risk (%)
Total 0 / 00 / 0

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Adverse Event Reporting Description does not appear to explain why the Number of Participants at Risk is zero.
Serious Adverse Events
  Liver Incyte With Patients With Successfully Treated HCV, or NAFLD/NASHLiver Incyte With Healthy Volunteers With no History of Liver Disease.
 Affected / At Risk (%)Affected / At Risk (%)
Total 0 / 00 / 0

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Adverse Event Reporting Description does not appear to explain why the Number of Participants at Risk is zero.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
  Liver Incyte With Patients With Successfully Treated HCV, or NAFLD/NASHLiver Incyte With Healthy Volunteers With no History of Liver Disease.
 Affected / At Risk (%)Affected / At Risk (%)
Total 0 / 00 / 0

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Adverse Event Reporting Description does not appear to explain why the Number of Participants at Risk is zero.
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title:
 Clinical Director
Organization:
 Sonic Incytes Medical Corp
Phone:
 1 800 881 0096
Email:
 support@sonicincytes.com
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