Versius Robotic Surgery in the NHS: A Multi-Specialty Retrospective Study

NCT07761299 — Recruiting, 1200 participants, CMR Surgical Ltd

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Robotic-Assisted Surgery With Versius in the NHS: Retrospective Comparative Performance Study Across Multiple Soft-Tissue Specialties

RegistryNCT07761299
StatusRecruiting
Study typeObservational
Enrollment1200 (Estimated)
SponsorCMR Surgical Ltd (Industry); collaborators: Watford General Hospital, University Hospital Southampton NHS Foundation Trust, Manchester University NHS Foundation Trust, St Thomas' Hospital, London, Great Western Hospitals NHS Foundation Trust
ConditionsRobotic-assisted Soft-tissue Surgery
Datesstart 2026-09-22, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-08-12, last updated 2026-10-16
Locations5 sites in United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Robotic-assisted Soft-tissue Surgery

-Summary

To generate robust, real-world comparative evidence on the short and long-term clinical outcomes following surgical intervention with Versius Robot-Assisted Surgery versus surgical standard of care across predefined soft-tissue index procedures in routine NHS practice.

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+Arms and interventions

ArmTypeInterventionsDescription
Versius Robotic-Assisted SurgeryPatients undergoing soft-tissue surgical procedures using the Versius Surgical System
Non-Versius Surgical CohortPatients undergoing comparable soft-tissue surgical procedures using non-Versius surgical approaches (conventional laparoscopic and open surgery).

+Outcome measures

Primary outcomes

  • Procedure related complication rates [Within 30 days and 12 months after surgery]: Rate of total procedure related complications within 30 days and up to 12 months following surgery

Secondary outcomes

  • Length of hospital stay [Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days]: Hospital stay in days from day of surgery until discharge
  • Conversion rate [Up to completion of surgery]: Proportion of surgical procedures requiring unplanned conversion to conventional laparoscopic or open surgery.
  • Operative time [Up to completion of surgery]: Surgical time from skin incision to skin closure
  • Revision surgery rate [Within 12 months following surgery]: Proportion of participants requiring revision surgery within 12 months following the index surgical procedure. Revision surgery is defined as any subsequent surgical procedure required as a result of the index surgical procedure or the underlying condition for which the index surgical procedure was performed.
  • Rate of pre-defined index procedure specific complications [Within 30 days and 12 months after surgery]: Percentage of participants who experience one or more pre-defined procedure-specific complications related to the index surgical procedure

+Eligibility

Sex: All

Inclusion Criteria:

1. Patients undergoing one of the index procedures with Versius, laparoscopically or with open surgery.
2. Patients who provide written consent (16 years or older) or for whom an appropriate legal representative who provides written informed consent (<16 years old).

Exclusion Criteria:

1. Patients participating in an interventional clinical study that might impact the defined endpoints.
2. Patients undergoing concomitant surgery.
3. Patients or appropriate legal representatives unwilling to provide written consent.
4. Patients with BMI at or above 40 kg/m2.

+Locations (5)

FacilityCityCountryStatus
St Thomas' HospitalLondonUnited KingdomNot yet recruiting
Manchester University NHS Foundation TrustManchesterUnited KingdomNot yet recruiting
University Hospital Southampton NHS Foundation TrustSouthamptonUnited KingdomNot yet recruiting
Great Western Hospitals NHS Foundation TrustSwindonUnited KingdomNot yet recruiting
Watford General HospitalWatfordUnited KingdomRecruiting

+Investigators

  • Paul Stanciu, Principal investigator, Watford General Hospital
  • Ewan Brownlee, Principal investigator, University Hospital Southampton NHS Foundation Trust
  • Ahmed Hassan, Principal investigator, Manchester University NHS Foundation Trust
  • Pankaj Mishra, Principal investigator, St Thomas' Hospital
  • Amy Keightley, Principal investigator, Great Western Hospitals NHS Foundation Trust