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

August 7, 2026 updated by: CMR Surgical Ltd

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Robotic-assisted Soft-tissue Surgery

Study Type

Observational

Enrollment (Estimated)

1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

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).

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure related complication rates Time Frame: Within 30 days and 12 months after surgery	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay Time Frame: 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	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
Operative time Time Frame: Up to completion of surgery	Surgical time from skin incision to skin closure	Up to completion of surgery
Conversion rate Time Frame: Up to completion of surgery	Proportion of surgical procedures requiring unplanned conversion to conventional laparoscopic or open surgery.	Up to completion of surgery
Revision surgery rate Time Frame: 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.	Within 12 months following surgery
Rate of pre-defined index procedure specific complications Time Frame: 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	Within 30 days and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMR Surgical Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 7, 2026

First Posted (Actual)

August 12, 2026

Study Record Updates

Last Update Posted (Actual)