Early evaluation of a next-generation surgical system in robot-assisted total laparoscopic hysterectomy: A prospective clinical cohort study.

ABSTRACT:

Introduction

This study aimed to demonstrate the safe and effective use of the Versius surgical system (CMR Surgical, Cambridge, UK) in robot-assisted total laparoscopic hysterectomy. This surgical robot was developed iteratively with input from surgeons to improve surgical outcomes and end-user experience. We report data from the gynecology cohort of an early clinical trial designed in broad alignment with IDEAL-D (Idea, Development, Exploration, Assessment, Long-term follow-up - Devices) stage 2b (Exploration).

Material and methods

The study is registered in the Indian clinical trials register (CTRI/2019/02/017872). Adult women requiring total hysterectomy who provided informed consent and met the eligibility criteria underwent procedures at one of three hospitals in India

SUBMITTER: Borse M 

PROVIDER: S-EPMC9564672 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature