超音速想象肝纤维化研究完成招生

StephenW

SuperSonic Imagine liver fibrosis study completes enrollment
July 8, 2016

   

SuperSonic Imagine announced completion of enrollment for a large prospective multicenter liver study in China. The company seeks to evaluate the performance of its real-time ShearWave Elastography for the non-invasive assessment of liver fibrosis in patients with chronic hepatitis B infection.


ShearWave Elastography (SWE) is an exam that provides a quantitative color coded map to visualize and quantify tissue stiffness during examination. Stiffness increases with the severity of liver fibrosis, making it a key parameter for physicians to assess the severity of liver fibrosis.

“We are committed to improving the lives of patients with liver fibrosis as a result of hepatitis B infection and are pleased to have completed enrollment in this key study,” Jacques Souquet, Supersonic Imagine’s founder and chief innovation officer, said in a press release, “Our ShearWave Elastography exam offers clinicians a non-invasive option that has demonstrated its value to help with the assessment of liver disease and clinical management of patients in several clinical publications. This prospective multicenter study in China will be a major step forward in the confirmation of this clinical value.”

The study has been conducted in 14 locations across China. Each of the 400 hepatitis B patients enrolled have received an ultrasound exam, including SWE, to measure liver stiffness and guide liver biopsy. In addition, all patients have had a blood test analysis. The next step is to analyze the outcome of these exams and evaluate the correlation between SWE measurements and liver fibrosis. Ultimately, this will lead to the assessment of the diagnostic performance of SWE.

“This study will provide new insights on ultrasound liver elasticity measurement and will help in evaluating the severity of intermediate stages of chronic liver fibrosis, which is key for effective treatment and management,” Professor Ping Liang, of the People’s Liberation Army Hospital and study investigator, said in the release.

StephenW

超音速想象肝纤维化研究完成招生
2016年7月8日

   

超音速想象公布招生完成对中国一家大型前瞻性多中心研究肝脏。该公司旨在评估它的实时ShearWave弹性成像肝纤维化患者的慢性乙肝感染的非侵入性评价的性能。


ShearWave弹性成像（SWE）是提供一个定量的颜色编码地图可视化和检查中量化组织硬度考试。刚度增加肝纤维化的严重性，使得它的一个重要参数为医师来评估肝纤维化的严重性。

“我们正在致力于提高肝纤维化患者的生命为乙肝感染的结果，很高兴能完成招生此项研究中，”雅克Souquet，超音速想象的创始人和首席创新官，在一份新闻稿中说， “我们ShearWave弹性成像考试提供临床医生已经证明它的价值，以帮助肝病和患者的临床管理的若干临床出版物评估一种非侵入性的选项。在中国，这种前瞻性多中心研究将在这个临床价值的确认迈出了重要的一步。“

该研究已在中国的14个地区已经进行。每个注册的400乙肝患者接受超声检查，包括瑞典，测量肝脏硬度和引导肝活检。此外，所有的患者都产生了血液测试分析。下一步骤是分析这些考试的结果，并评估SWE测量和肝纤维化的相关性。最终，这将导致SWE的诊断性能的评估。

“这项研究将提供超声肝脏弹性测量新的见解，将在评估慢性肝纤维化，这是有效的治疗和管理的关键的中间阶段的严重性帮助，”梁萍教授解放军医院和研究调查员在发布会上说。