Versius Surgical System in Transoral Robotic Surgery (TORS)

• Research type

  Research Study

• Full title

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

• IRAS ID

  326350

• Contact name

  Jason Fleming

• Contact email

  jason.fleming@liverpool.ac.uk

• Sponsor organisation

  CMR Surgical Limited

• Clinicaltrials.gov Identifier

  NCT06112535

• Duration of Study in the UK

  1 years, 2 months, 1 days

• Research summary

  A single-arm, single site case series cohort prospective 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. The main objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. These are procedures where surgical instruments are inserted through the mouth/throat to remove sick tissue rather than skin incisions. Patients' care and all follow-ups will be as per standard clinical practice, site policy, GCP and national regulatory requirements.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  23/LO/0393

• Date of REC Opinion

  13 Jun 2023

• REC opinion

  Further Information Favourable Opinion