Vitrani Marie-Aude, Baumann Michael, Reversat David, Morel Guillaume, Moreau-Gaudry Alexandre, Mozer Pierre
UMR 7222, ISIR, Sorbonne Universités UPMC Univ. Paris 06, Paris, France.
INSERM, U1150, Agathe-ISIR, 75005, Paris, France.
Int J Comput Assist Radiol Surg. 2016 Jun;11(6):1153-61. doi: 10.1007/s11548-016-1399-y. Epub 2016 Apr 12.
A comanipulator for assisting endorectal prostate biopsies is evaluated through a first-in-man clinical trial. This lightweight system, based on conventional robotic components, possesses six degrees of freedom. It uses three electric motors and three brakes. It features a free mode, where its low friction and inertia allow for natural manipulation of the probe and a locked mode, exhibiting both a very low stiffness and a high steady-state precision.
Clinical trials focusing on the free mode and the locked mode of the robot are presented. The objective was to evaluate the practical usability and performance of the robot during clinical procedures. A research protocol for a prospective randomized clinical trial has been designed. Its specific goal was to compare the accuracy of biopsies performed with and without the assistance of the comanipulator.
The accuracy is compared between biopsies performed with and without the assistance of the comanipulator, across the 10 first patients included in the trial. Results show a statistically significant increase in the precision.
通过一项人体首次临床试验对一种用于辅助直肠内前列腺活检的协同操作器进行评估。这个基于传统机器人组件的轻型系统具有六个自由度。它使用三个电动马达和三个制动器。它具有自由模式，其低摩擦力和惯性允许对探头进行自然操作，还有锁定模式，表现出极低的刚度和高稳态精度。
介绍了聚焦于机器人自由模式和锁定模式的临床试验。目的是评估机器人在临床操作过程中的实际可用性和性能。设计了一项前瞻性随机临床试验的研究方案。其具体目标是比较在有和没有协同操作器辅助的情况下进行活检的准确性。
在该试验纳入的前10名患者中，比较了有和没有协同操作器辅助下进行活检的准确性。结果显示精度有统计学上的显著提高。
