Evaluation of a novel radial echoendosonoscope with a piezoelectric-composite transducer: An open-label, multicenter, randomized, parallel-group, noninferiority clinical trial

BACKGROUND AND OBJECTIVES: EUS is widely used in the clinical practice. This study aimed to evaluate the efficacy of a novel echoendoscope regarding image quality, maneuverability, stability of the entire machine system, and safety. SETTING AND DESIGN: We conducted this open-label, multicenter, randomized, parallel-group, noninferiority clinical trial in three tertiary hospitals between November 2018 and April 2019. SUBJECTS AND METHODS: One hundred and thirty patients were included. The stratified segment randomization method was employed. Sixty-five patients in the test group received an EUS examination using the new material radial echoendoscope, and 65 patients in the control group received an EUS examination using the existing endoscope. We recorded the image quality, maneuverability, stability of the entire machine system, and safety. For the main outcome, comprehensive image quality, the groups were compared with the noninferiority test, using the confidence interval method and 10% as the noninferiority threshold. The Pearson Chi-square test was used to compare the incidence of adverse events between the groups. RESULTS: Sixty-five patients in the test group and 63 patients in the control group were analyzed. Two patients in control group did not complete an EUS examination due to machine problems. There were no significant differences in image quality, maneuverability of the echoendoscope, stability of the entire machine system, and safety between the groups. CONCLUSIONS: This new material radial echoendoscope showed good capabilities for image quality, maneuverability, stability of the entire machine system, and safety. Our data suggest that the new echoendoscope may provide an additional option for endoscopic physicians.