Fatty LiverNCT02456766
Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis
An observational study of Fatty Liver and Hepatic Steatosis, run by Wuxi Hisky Medical Technology Co Ltd at 8 sites in China.
Trial summary
This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatty Liver, Hepatic Steatosis, Liver Steatosis
- What is being tested?
- FibroTouch and Liver Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 240 participants
- Where
- 8 sitesChina
- Study dates
- Jun 2014to Jun 2015
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
Who may be able to join
- Subject at the age of 18 to 65 years, non-limited gender.
- Within two weeks of FibroTouch examination, qualified histological specimens of liver biopsy are required. Using the liver biopsy needle of 16G or 14CT, puncture and remove more than 2.0 centimeters long liver tissue (including at least 11 portal areas, no less than 6 complete portal areas and the minimum length of specimen should be more than 1.0 centimeter).
- Willing and able to abide by all principles and complete all study procedures.
- Willing and can provide written informed consent form by patient or patient's legal guardian.
Who cannot join
- Subject with active or suspected cancer or history of malignant tumor by evidence within 5 years before enrolling. And the subject who has the liver malignant tumors injury cannot participate in this study.
- There is evidence that the subject has a history of alcohol overdoses* or drug abuse. Definition of alcohol overdoses: 40 gram (g)/day for male and 40 g/day for female. Alcohol intake (g) = the volume of drinking (ml) × alcohol percentage (%, v/v) × 0.8 (g/ml); 1g alcohol is the equal of 25-40 ml of beer, 8-10ml of Chinese rice wine, 5-12ml of (grape) wine, 3-7ml of health care liquor or Chinese spirits.
- Subject with alcoholic liver disease and hepatitis C.
- Pregnant or nursing woman, and subject with a pregnant plan and is unwilling to take contraceptive measures during this study.
- Subject with history of organ transplantation or has functional grafts (except for the cornea or hair graft).
- Subject with non-healing wound on the right upper abdomen at this moment.
- In the investigator's opinion, the subject is unsuitable to participate in the study as he or she has a history of serious illness, or other evidence shown that the subject has any other serious illness.
- Subject who participates in other clinical trial at the same time.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
Chengdu
Liangping LI, MD
- Recruiting
Guangzhou First Municipal People's Hospital
Guangzhou
Yongjian ZHOU, MD
- Recruiting
Second People's Hospital of Hangzhou
Hangzhou
Junping SHI, MD
- Recruiting
The Second Hospital Of Nanjing
Nanjing
Yongfeng YANG, MD
- Recruiting
Ruijin Hospital
Shanghai
Qing XIE, MD
- Recruiting
Shanghai 85 Hospital
Shanghai
Qingchun FU, MD
- Recruiting
Shanghai First People's Hospital
Shanghai
Lungen LU, MD, lungenlu1965@163.com
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Jiangao FAN, MD
About this study
Official title: A Multicenter Clinical Study on the Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for the Diagnosis of Hepatic Steatosis
This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56 effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of liver steatosis will be identified.
The patients with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
- Conditions
- Fatty Liver, Hepatic Steatosis, Liver Steatosis
- Being tested
- FibroTouch, Liver Biopsy
- Keywords
- FibroTouch, acoustic attenuation parameter, liver biopsy, hepatic steatosis
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroTouchDevice
Liver BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| F0 | Liver Steatosis Grade: <5% Receives: Device: FibroTouch; Procedure: Liver Biopsy | |
| F1 | Liver Steatosis Grade: 5-33% Receives: Device: FibroTouch; Procedure: Liver Biopsy | |
| F2 | Liver Steatosis Grade: 34-66% Receives: Device: FibroTouch; Procedure: Liver Biopsy | |
| F3 | Liver Steatosis Grade: > 66% Receives: Device: FibroTouch; Procedure: Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis
Performance of fat attenuation parameter (FAP, dB/m) of FibroTouch will be assessed using ROC analysis for the detection of hepatic steatosis stage F0 (<5%), stage F1 (5%-33%), stage F2 (34%-66%), and stage F3 (2>66%) using liver biopsy as the reference.
Measured: Within two weeks of FibroTouch examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi Hisky Medical Technology Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Guangzhou First People's Hospital, Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, No.85 Hospital, Changning, Shanghai, China, The Second Hospital of Nanjing Medical University, Sichuan Academy of Medical Sciences, Second People's Hospital of Hangzhou
- Responsible party
- Sponsor
- Investigators
- Lungen LU, MD, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456766
- Sponsor's protocol ID
- TG1310FT
- Status last verified
- May 2015
- First submitted
- 22 Mar 2015
- Last updated
- 28 May 2015
- Results posted
- No
Publications
Qu Y, Song YY, Chen CW, Fu QC, Shi JP, Xu Y, Xie Q, Yang YF, Zhou YJ, Li LP, Xu MY, Cai XB, Zhang QD, Yu H, Fan JG, Lu LG. Diagnostic Performance of FibroTouch Ultrasound Attenuation Parameter and Liver Stiffness Measurement in Assessing Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Clin Transl Gastroenterol. 2021 Apr 13;12(4):e00323. doi: 10.14309/ctg.0000000000000323.
PubMed 33848277
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on the Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for the Diagnosis of Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT02456766
- Acronym / sponsor ID
- TG1310FT
- Conditions
- Fatty Liver, Hepatic Steatosis, Liver Steatosis
- Keywords
- FibroTouch, acoustic attenuation parameter, liver biopsy, hepatic steatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Wuxi Hisky Medical Technology Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Guangzhou First People's Hospital, Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, No.85 Hospital, Changning, Shanghai, China, The Second Hospital of Nanjing Medical University, Sichuan Academy of Medical Sciences, Second People's Hospital of Hangzhou
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 May 2015 (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.
This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56 effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of liver steatosis will be identified.
The patients with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| F0 | – | Device: FibroTouch, Procedure: Liver BiopsyLiver Steatosis Grade: <5% |
| F1 | – | Device: FibroTouch, Procedure: Liver BiopsyLiver Steatosis Grade: 5-33% |
| F2 | – | Device: FibroTouch, Procedure: Liver BiopsyLiver Steatosis Grade: 34-66% |
| F3 | – | Device: FibroTouch, Procedure: Liver BiopsyLiver Steatosis Grade: > 66% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
Key inclusion criteria (4 listed)
- Subject at the age of 18 to 65 years, non-limited gender.
- Within two weeks of FibroTouch examination, qualified histological specimens of liver biopsy are required. Using the liver biopsy needle of 16G or 14CT, puncture and remove more than 2.0 centimeters long liver tissue (including at least 11 portal areas, no less than 6 complete portal areas and the minimum length of specimen should be more than 1.0 centimeter).
- Willing and able to abide by all principles and complete all study procedures.
- Willing and can provide written informed consent form by patient or patient's legal guardian.
Key exclusion criteria (8 listed)
- Subject with active or suspected cancer or history of malignant tumor by evidence within 5 years before enrolling. And the subject who has the liver malignant tumors injury cannot participate in this study.
- There is evidence that the subject has a history of alcohol overdoses* or drug abuse. Definition of alcohol overdoses: 40 gram (g)/day for male and 40 g/day for female. Alcohol intake (g) = the volume of drinking (ml) × alcohol percentage (%, v/v) × 0.8 (g/ml); 1g alcohol is the equal of 25-40 ml of beer, 8-10ml of Chinese rice wine, 5-12ml of (grape) wine, 3-7ml of health care liquor or Chinese spirits.
- Subject with alcoholic liver disease and hepatitis C.
- Pregnant or nursing woman, and subject with a pregnant plan and is unwilling to take contraceptive measures during this study.
- Subject with history of organ transplantation or has functional grafts (except for the cornea or hair graft).
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 |
|---|---|---|
| FibroTouch | Device | F0, F1, F2, F3 |
| Liver Biopsy | Procedure or surgery | F0, F1, F2, F3 |
Primary outcome
The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis
Time frame: Within two weeks of FibroTouch examination
Performance of fat attenuation parameter (FAP, dB/m) of FibroTouch will be assessed using ROC analysis for the detection of hepatic steatosis stage F0 (<5%), stage F1 (5%-33%), stage F2 (34%-66%), and stage F3 (2>66%) using liver biopsy as the reference.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 33848277Qu Y, Song YY, Chen CW, Fu QC, Shi JP, Xu Y, Xie Q, Yang YF, Zhou YJ, Li LP, Xu MY, Cai XB, Zhang QD, Yu H, Fan JG, Lu LG. Diagnostic Performance of FibroTouch Ultrasound Attenuation Parameter and Liver Stiffness Measurement in Assessing Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Clin Transl Gastroenterol. 2021 Apr 13;12(4):e00323. doi: 10.14309/ctg.0000000000000323.
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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.
Lungen LU, MD study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver and Hepatic Steatosis, run by Wuxi Hisky Medical Technology Co Ltd at 8 sites in China.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng LU, Bachelor (+86-10-62701872, lupeng@fibrotouch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis (time frame: Within two weeks of FibroTouch examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02456766, which also lists 1 linked publication.
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 28 May 2015.