LivQ-box® Parameters in the Diagnosis of Liver Inflammation | NCT06802731

Studies
LivQ-box® Parameters in the Diagnosis of Liver Inflammation

NCT06802731

Sponsor

Wuxi Hisky Medical Technology Co Ltd

Status

Recruiting

Last Update Posted

Jan 31, 2025Actual

Enrollment

365Estimated

Phase

Not provided

Conditions

Liver Inflammation
Fatty Liver Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Jan 13, 2025

First Submission Date that Met QC Criteria

Jan 24, 2025

First Posted Date

Jan 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2025

Last Update Posted Date

Jan 31, 2025Actual

Name	Class
Beijing Tsinghua Changgeng Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.

Detailed Description

This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

365Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
Age over 18 years old, gender not limited;
Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
Perform iLivTouch examination within ± 14 days of liver pathology examination;
No history of excessive alcohol consumption (converted to ethanol:<140g/week for males,<70g/week for females);

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lai Wei	Contact	+86 13601281862		weilai@pkuph.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University	Recruiting	Beijing	Beijing Municipality	102218	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32077608	Background	Negro F. Natural history of NASH and HCC. Liver Int. 2020 Feb;40 Suppl 1:72-76. doi: 10.1111/liv.14362.
32012320	Background	Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.

ID	Term
D006505	Hepatitis
D065626	Non-alcoholic Fatty Liver Disease

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005234	Fatty Liver