A new clinical trial has been announced to evaluate the performance of a handheld elastography device compared with iLivTouch for patients diagnosed with chronic liver diseases such as metabolic-associated fatty liver disease (MAFLD) and chronic hepatitis B. This trial, sponsored by Hong You, aims to assess advancements in medical device capabilities for liver disease diagnostics. The trial is listed as not yet recruiting as of November 2025.
In this article:
- What changed?
- How is the trial designed?
- What are the potential impacts?
- FAQs
- Conclusion
- Important disclaimer
- For full announcement
What changed?
The announcement of this clinical trial marks another step towards improving diagnostic tools in hepatology. The handheld elastography device under study may provide healthcare professionals with a novel way to measure liver elasticity and stiffness, which are critical parameters for assessing liver damage. With both MAFLD and chronic hepatitis B listed as trial conditions, the study seeks to address diagnostic needs for two prevalent diseases that pose global health challenges.
How is the trial designed?
The trial will focus on comparing the performance of the handheld elastography device and the iLivTouch system, both designed for imaging and assessing liver stiffness. While iLivTouch has established credibility in this diagnostic area, the study may reveal whether the handheld device can match or exceed current standard methods in terms of accuracy, usability, and reliability.
Clinical trials.gov has recorded that recruitment has not yet started as of the publication date. It is anticipated that Hong You, the trial sponsor, will provide further information on patient eligibility and trial timelines soon. Both regulatory and clinical teams need to remain updated to analyze potential device approvals once efficacy is established.
What are the potential impacts?
If proven effective, the handheld elastography device could benefit clinicians by offering a portable, cost-effective, and easy-to-use tool that enhances liver disease management. Such innovations align with global efforts to address the rising prevalence of liver conditions without overburdening healthcare resources.
Furthermore, positive results from this study could influence medical device market dynamics and regulatory pathways for liver diagnostic tools. Regulatory advisers should closely monitor this trial for evidence that supports clearance or approvals, as well as market adoption trajectories.
FAQs
1. What is a handheld elastography device? A handheld elastography device measures liver stiffness by using imaging technology to assess tissue elasticity.
2. What makes iLivTouch relevant? iLivTouch is a known diagnostic tool used to monitor liver stiffness with high precision, often used as a benchmark in hepatology.
3. What conditions does this trial encompass? The trial targets patients living with MAFLD and chronic hepatitis B, among the most common liver diseases globally.
Conclusion
The scheduled comparison of the handheld elastography device with iLivTouch provides an important opportunity to advance diagnostic options for chronic liver diseases. Clinical and regulatory stakeholders should remain alert to developments in this trial and analyze its findings for broader implications in hepatology practice and device pathways.
Important disclaimer
The information in this article is intended for professionals involved in healthcare and medical device regulatory activities. This content does not constitute legal advice. Readers should consult relevant authorities or experts for compliance-specific guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07242404?term=medical+device