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NCT03342560 · ClinicalTrials.gov registry record · NA
Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03342560: Completed NA study, sponsored by Massachusetts General Hospital.
NCT03342560 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03342560, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of stage of liver fibrosis and steatosis in patients with diffuse liver disease exists due to different methods of measurements, and/or different systems. The proposed investigation is a cross-sectional study using ultrasound elastography and fat quantification modalities. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care. The investigators will use 4 different ultrasound devices with their shear wave elastography and speed of sound functions. Specific aims; * Compare shear wave elastography(SWE) measurements from different ultrasound systems; using histopathology as reference standards. * Assess intra-operator and inter-operator reliability by measuring variability in elastography values by two operators on a single system. * Determine the effect of deviations from guidelines(less number of measurements and measurements during active breath)
Interventions
- DEVICE Sonographic SWE measurements with 4 different ultrasound systems
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2018-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03342560
The ClinicalTrials.gov registry entry for NCT03342560 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sonographic SWE measurements with 4 different ultrasound systems is the first listed.
NCT03342560 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03342560 about?
NCT03342560 is a clinical study titled "Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography". Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of sta...
What is the current status of trial NCT03342560?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2017-06-29. Estimated completion is 2018-08-30.
What interventions are being tested in trial NCT03342560?
The interventions under investigation include: Sonographic SWE measurements with 4 different ultrasound systems (DEVICE).
Who is sponsoring clinical trial NCT03342560?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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