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

NCT07761299 | Not Yet Recruiting

• 1 other identifier: CA-00671
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Robotic-assisted Soft-tissue Surgery

Outcome Measures

Primary Outcomes (1)

• Procedure related complication rates

  Rate of total procedure related complications within 30 days and up to 12 months following surgery

  Within 30 days and 12 months after surgery

Secondary Outcomes (5)

• 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

• Conversion rate

  Up to completion of surgery

• Operative time

  Up to completion of surgery

• Revision surgery rate

  Within 12 months following surgery

• Rate of pre-defined index procedure specific complications

  Within 30 days and 12 months after surgery

Study Arms (2)

Versius Robotic-Assisted Surgery

Patients undergoing soft-tissue surgical procedures using the Versius Surgical System

Non-Versius Surgical Cohort

Patients undergoing comparable soft-tissue surgical procedures using non-Versius surgical approaches (conventional laparoscopic and open surgery).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing soft-tissue surgical procedures using the Versius Surgical System or a comparator surgical approach (laparoscopic or open surgery).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CMR Surgical Ltd: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share