NCT06112535

Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: CMR Surgical Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, single site, multi-surgeon prospective feasibility study for transoral robot assisted surgery (TORS) with the Versius Surgical System. Versius is a robotic system designed to help in the accurate control of surgical instruments for minimal access ("keyhole") surgery. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).

Conditions

• Squamous Cell Carcinoma of the Oropharynx
• Squamous Cell Carcinoma, Unknown Primary

Interventions

Type	Name	Description
DEVICE	Versius Surgical System	Transoral robotic surgery (TORS) using Versius Surgical System. Versius is a robot designed to help surgeons perform surgery. It consists of a set of robotic arms: one of the arms has a camera and a light source on it while the other arms each have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them, while seeing the surgical area on a screen in front of him/her. The camera and instruments are inserted into the mouth and throat in order to cut out a cancerous tumour.

Timeline

• Start date: 2023-12-13
• Primary completion: 2025-04-16
• Completion: 2025-04-22
• First posted: 2023-11-01
• Last updated: 2025-06-25

Locations

1 site across 1 country: United Kingdom