Nonalcoholic SteatohepatitisNCT04828551
Noninvasive Biomarkers of Metabolic Liver Disease 1.1
A study testing Ultrasound based shear wave speed and fat quantification methods, Blood collection and Physical measurements in people with Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
NIMBLE is a comprehensive collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver
- What is being tested?
- Ultrasound based shear wave speed and fat quantification methods, Blood collection and Physical measurements
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Mar 2021to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age ≥ 18 years)
- Known or suspected NAFLD based on prior biopsy ≤ 36 months consistent with NAFLD OR
- Abnormal ALT (>30 U/L for men, > 19 U/L for women) without other common causes such as HCV, HBV, AND meets criteria within 36 months for ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 5:
- Waist circumference (WC) > 102 cm (M) or > 88 cm (F)
- Fasting glucose ≥ 100 mg/dL or Rx
- TG≥150mg/dLorRx
Show all 11Show fewer
- SBP > 130 mmHg
- DBP>85mmHg or Rx
- Able and willing to participate, including maintaining steady-state: physical activity, alcohol use, medications
- Classifiable into one of the following enrollment categories by FIB-4 (ALT, AST, platelets, date of birth) collected at screening visit if not available already within 3 months prior:
- Low likelihood of advanced fibrosis: FIB-4 ≤ 1.3 (about one-third of enrolled participants, minimum 8, maximum 18), Intermediate likelihood of advanced fibrosis: 1.3 < FIB-4 < 2.67 (about one-third of enrolled participants, minimum 8, maximum 18), High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled participants, minimum 8, maximum 18)
Who cannot join
- Liver disease other than NAFLD
- Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men)
- Current diagnosis of drug induced liver injury
- Receiving drug or placebo in treatment trial now or within 30 days
- Weight loss or gain of ≥ 5 kg in prior 3 months
- Other factors that in the judgment of the principal investigator might preclude study completion
- Women who state they are pregnant. Women who state they are pregnant will be excluded in an abundance of caution, since pregnancy might increase intra-abdominal pressure which in turn might affect the assessment of the different-day reproducibility coefficient of ultrasound and VCTE measurements. Women who state they might be pregnant will be required to do a urine pregnancy test to establish eligibility.
- Patients with active implants such as pacemakers or defibrillators or any other contraindication to ultrasound or VCTE scanning.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
UC San Diego
San Diego, California, 92103
About this study
NIMBLE is a comprehensive collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble). This study focuses on estimating the repeatability and reproducibility of ultrasound elastography-based biomarkers across a range of fibrosis stages.
Read the detailed description
Study 1.1, is a prospective, two-center, short-term cross-sectional study to assess the reproducibility and repeatability of a set of specified ultrasound-based quantitative imaging biomarkers. The primary focus will be on imaging biomarkers of the liver fibrosis component of nonalcoholic fatty liver disease (NAFLD), rather than the steatosis or inflammation component. The rationale is that the fibrosis component is linked most closely to survival and other clinical outcomes. Study 1.1 will also collect data to explore vendor- or device-specific investigational biomarkers on other components of NAFLD such as steatosis and possibly inflammation.
- Being tested
- Ultrasound based shear wave speed and fat quantification methods, Blood collection, Physical measurements, Clinical history and medication reviews
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound based shear wave speed and fat quantification methodsDevice
Ultrasound based imaging parameters will be collected from all patients in two visits. These will include but may not be limited to SWE results, Quantitative ultrasound parameters,where available,including Attenuation Coefficient, Backscatter Coefficient, Shear Wave Dispersion, Speed of Sound, Ultrasound derived fat fraction Conventional Bmode (gray-scale) and Doppler ultrasound images,including An image of the liver and right kidney on the same image for hepatorenal index calculation Right liver lobe for skin to liver capsule distance calculation Portal vein Doppler for portal vein pulsatility index measurement VCTE and Controlled Attenuation Parameter measurements with the Fibroscan system
Blood collectionDiagnostic test
Blood will be collected by trained phlebotomists at each site using routine methods and standard collection tubes.
Total volume is expected to be about 10 mL or less Blood collected at MGH will be analyzed by the MGH clinical laboratory. Blood collected at UCSD will be analyzed by the UCSD clinical laboratory. Blood results obtained within the 3-month interval prior to the screening visit at the MGH or UCSD laboratories will be considered acceptable for study analyses and may be used at PI discretion. For each laboratory, the normal ranges for each blood test will be recorded and filed
Physical measurementsOther
Height will be recorded at Screening. Weight and vital signs will be recorded at each visit. Body mass index will be calculated at each visit. All measurements will be made by trained coordinators using standard and calibrated instruments.
Clinical history and medication reviewsOther
The following questionnaires will be administered at Screening:
Medical history questionnaire Medication use questionnaire Alcohol consumption questionnaire Physical activity questionnaire
The following questionnaires will be administered at Visit 1 and Visit 2:
Interim medical history questionnaire Change in medication use questionnaire Change in alcohol consumption will be recorded using a modified version of the alcohol use followback. Alcohol use for the 7 day period prior to Visit 1 and for all days between Visit 1 and Visit 2 will be recorded. Change in physical activity questionnaire
| Study group | Role | What they receive |
|---|---|---|
| MGH and UCSD Study subjects | Other | This study will enroll patients with suspected or confirmed diagnosis of NAFLD. Based on protocol-specified FIB-4 values, about one-third are expected to have low, one-third to have intermediate, and one-third to have high likelihood of advanced fibrosis.
Sex: 50:50 - Note- no stratification will be done based on sex Age: ≥ 18 yrs Demographic group: Patients with a high probability of NAFLD based on the eligibility criteria General health status: Patients with suspected or confirmed diagnosis of NAFLD Geographic location: Boston, MA (greater metropolitan areas) and San Diego, CA (greater metropolitan areas) Receives: Device: Ultrasound based shear wave speed and fat quantification methods; Diagnostic Test: Blood collection; Other: Physical measurements; Other: Clinical history and medication reviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Pooled Different-day, Different-operator Reproducibility of Shear Wave Speed Measurements
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of ultrasound measurements of shear wave speed, is reported in the outcome measure data table section.
Measured: (2 visits, baseline + up to 7 days). Outcome measure will be assessed after pooling measurements from all study subjects.
Different-day, Different-operator Reproducibility Coefficient of Transient Elastography Based Shear Wave Speed Measurements
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of transient elastography measurements (in m/s unit), is reported in the outcome measure data table section.
Measured: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.
Secondary outcomes (3)
Evaluation of Pooled Same-day, Same-operator Repeatability of Shear Wave Speed (SWS)
The same research subject undergoes multiple SWE measurements (in m/s) on multiple devices and transient elastography (TE) at two visits (in 7 days) with different operators. For this outcome measure, the same-day same-operator repeatability is estimated on repeated measurements performed on the same device by the same operator at the same visit. For example, the following structure is followed for a subject; Day1 (Device A, Device B, Device C, TE, Repeated Device A, Repeated Device B), Day2 (Device A, Device B, Device C, TE, Repeated Device C, Repeated TE). The median SWS value (in m/s) is computed for each ultrasound device and is displayed by the TE device. The pooled same-day, same-operator repeatability coefficient of ultrasound measurements of SWS, is reported in the outcome measure data table section.
Measured: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling measurements from all study subjects.
Evaluation of Pooled Different-scanner, Same-day Reproducibility of Shear Wave Elastography.
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The reproducibility coefficient of measurements obtained across different ultrasound devices on the same day by the same operator is computed. For example, the following structure is followed for a study subject; Day1 (Device A, Device B, Device C, Transient elastography, Repeated Device A, Repeated Device B), Day2 (Device A, Device B, Device C, Transient elastography, Repeated Device C, Repeated transient elastography).The pooled different-scanner, same-day reproducibility coefficient of ultrasound measurements of SWS, is reported in the outcome measure data table section.
Measured: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.
Evaluation of Same-day, Same-operator Repeatability of Transient Elastography
Same day same operator repeat median TE measures expressed in m/s are compared and the repeatability is estimated. For example, the following structure is followed for a study subject; Day1 (Device A, Device B, Device C, Transient elastography, Repeated Device A, Repeated Device B), Day2 (Device A, Device B, Device C, Transient elastography, Repeated Device C, Repeated transient elastography), which allows estimation of same-day same operator repeatability.
Measured: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start18 Mar 2021
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Foundation for the National Institutes of Health
- Responsible party
- Principal investigator, Anthony Samir, Massachusetts General Hospital
- Investigators
- Anthony E Samir, MD, MPH, Principal investigator, Massachusetts General HospitalKathryn Fowler, MD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828551
- Sponsor's protocol ID
- 2019P002092
- Status last verified
- Jun 2023
- First submitted
- 24 Mar 2021
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Pierce TT, Ozturk A, Sherlock SP, Moura Cunha G, Wang X, Li Q, Hunt D, Middleton MS, Martin M, Corey KE, Edenbaum H, Shankar SS, Heymann H, Kamphaus TN, Calle RA, Covarrubias Y, Loomba R, Obuchowski NA, Sanyal AJ, Sirlin CB, Fowler KJ, Samir AE. Reproducibility and Repeatability of US Shear-Wave and Transient Elastography in Nonalcoholic Fatty Liver Disease. Radiology. 2024 Sep;312(3):e233094. doi: 10.1148/radiol.233094.
PubMed 39254458
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Biomarkers of Metabolic Liver Disease 1.1
- ClinicalTrials.gov ID
- NCT04828551
- Acronym / sponsor ID
- 2019P002092
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of California, San Diego, Foundation for the National Institutes of Health
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NIMBLE is a comprehensive collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble). This study focuses on estimating the repeatability and reproducibility of ultrasound elastography-based biomarkers across a range of fibrosis stages.
Detailed description
Study 1.1, is a prospective, two-center, short-term cross-sectional study to assess the reproducibility and repeatability of a set of specified ultrasound-based quantitative imaging biomarkers. The primary focus will be on imaging biomarkers of the liver fibrosis component of nonalcoholic fatty liver disease (NAFLD), rather than the steatosis or inflammation component. The rationale is that the fibrosis component is linked most closely to survival and other clinical outcomes. Study 1.1 will also collect data to explore vendor- or device-specific investigational biomarkers on other components of NAFLD such as steatosis and possibly inflammation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGH and UCSD Study subjects | Other | Device: Ultrasound based shear wave speed and fat quantification methods, Diagnostic Test: Blood collection, Other: Physical measurements, Other: Clinical history and medication reviewsThis study will enroll patients with suspected or confirmed diagnosis of NAFLD. Based on protocol-specified FIB-4 values, about one-third are expected to have low, one-third to have intermediate, and one-third to have high likelihood of advanced fibrosis. Sex: 50:50 - Note- no stratification will be done based on sex Age: ≥ 18 yrs Demographic group: Patients with a high probability of NAFLD based on the eligibility criteria General health status: Patients with suspected or confirmed diagnosis of NAFLD Geographic location: Boston, MA (greater metropolitan areas) and San Diego, CA (greater metropolitan areas) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult (age ≥ 18 years)
- Known or suspected NAFLD based on prior biopsy ≤ 36 months consistent with NAFLD OR
- Abnormal ALT (>30 U/L for men, > 19 U/L for women) without other common causes such as HCV, HBV, AND meets criteria within 36 months for ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 5:
- Waist circumference (WC) > 102 cm (M) or > 88 cm (F)
- Fasting glucose ≥ 100 mg/dL or Rx
Key exclusion criteria (8 listed)
- Liver disease other than NAFLD
- Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men)
- Current diagnosis of drug induced liver injury
- Receiving drug or placebo in treatment trial now or within 30 days
- Weight loss or gain of ≥ 5 kg in prior 3 months
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 |
|---|---|---|
| Ultrasound based shear wave speed and fat quantification methodsUltrasound based imaging parameters will be collected from all patients in two visits. These will include but may not be limited to SWE results, Quantitative ultrasound parameters,where available,including Attenuation Coefficient, Backscatter Coefficient, Shear Wave Dispersion, Speed of Sound, Ultrasound derived fat fraction Conventional Bmode (gray-scale) and Doppler ultrasound images,including An image of the liver and right kidney on the same image for hepatorenal index calculation Right liver lobe for skin to liver capsule distance calculation Portal vein Doppler for portal vein pulsatility index measurement VCTE and Controlled Attenuation Parameter measurements with the Fibroscan system | Device | MGH and UCSD Study subjects |
| Blood collectionBlood will be collected by trained phlebotomists at each site using routine methods and standard collection tubes. Total volume is expected to be about 10 mL or less Blood collected at MGH will be analyzed by the MGH clinical laboratory. Blood collected at UCSD will be analyzed by the UCSD clinical laboratory. Blood results obtained within the 3-month interval prior to the screening visit at the MGH or UCSD laboratories will be considered acceptable for study analyses and may be used at PI discretion. For each laboratory, the normal ranges for each blood test will be recorded and filed | Diagnostic test | MGH and UCSD Study subjects |
| Physical measurementsHeight will be recorded at Screening. Weight and vital signs will be recorded at each visit. Body mass index will be calculated at each visit. All measurements will be made by trained coordinators using standard and calibrated instruments. | Other | MGH and UCSD Study subjects |
| Clinical history and medication reviewsThe following questionnaires will be administered at Screening: Medical history questionnaire Medication use questionnaire Alcohol consumption questionnaire Physical activity questionnaire The following questionnaires will be administered at Visit 1 and Visit 2: Interim medical history questionnaire Change in medication use questionnaire Change in alcohol consumption will be recorded using a modified version of the alcohol use followback. Alcohol use for the 7 day period prior to Visit 1 and for all days between Visit 1 and Visit 2 will be recorded. Change in physical activity questionnaire | Other | MGH and UCSD Study subjects |
Primary outcome
Evaluation of Pooled Different-day, Different-operator Reproducibility of Shear Wave Speed Measurements
Time frame: (2 visits, baseline + up to 7 days). Outcome measure will be assessed after pooling measurements from all study subjects.
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of ultrasound measurements of shear wave speed, is reported in the outcome measure data table section.
Different-day, Different-operator Reproducibility Coefficient of Transient Elastography Based Shear Wave Speed Measurements
Time frame: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of transient elastography measurements (in m/s unit), is reported in the outcome measure data table section.
3 secondary outcomes
Evaluation of Pooled Same-day, Same-operator Repeatability of Shear Wave Speed (SWS)
Time frame: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling measurements from all study subjects.
Evaluation of Pooled Different-scanner, Same-day Reproducibility of Shear Wave Elastography.
Time frame: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.
Evaluation of Same-day, Same-operator Repeatability of Transient Elastography
Time frame: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39254458Pierce TT, Ozturk A, Sherlock SP, Moura Cunha G, Wang X, Li Q, Hunt D, Middleton MS, Martin M, Corey KE, Edenbaum H, Shankar SS, Heymann H, Kamphaus TN, Calle RA, Covarrubias Y, Loomba R, Obuchowski NA, Sanyal AJ, Sirlin CB, Fowler KJ, Samir AE. Reproducibility and Repeatability of US Shear-Wave and Transient Elastography in Nonalcoholic Fatty Liver Disease. Radiology. 2024 Sep;312(3):e233094. doi: 10.1148/radiol.233094.
- Individual participant dataSharing planned: Yes
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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.
Anthony E Samir, MD, MPH principal investigator
Massachusetts General Hospital
Kathryn Fowler, MD principal investigator
UC San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound based shear wave speed and fat quantification methods, Blood collection and Physical measurements in people with Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver, run by Massachusetts General Hospital at 2 sites in United States.
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 11 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: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Pooled Different-day, Different-operator Reproducibility of Shear Wave Speed Measurements (time frame: (2 visits, baseline + up to 7 days). Outcome measure will be assessed after pooling measurements from all study subjects.). The study lists 2 primary outcomes in all. 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 NCT04828551, 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 11 Jul 2023.