Robotic-assisted Soft-tissue SurgeryNCT07761299
Versius Robotic Surgery in the NHS: A Multi-Specialty Retrospective Study
An observational study of Robotic-assisted Soft-tissue Surgery, run by CMR Surgical Ltd at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Robotic-assisted Soft-tissue Surgery
- How many people
- 1,200 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 22 Sep 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing soft-tissue surgical procedures using the Versius Surgical System or a comparator surgical approach (laparoscopic or open surgery).
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Diana Toderita contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
St Thomas' Hospital
London
Pankaj Mishra
- Not yet recruiting
Manchester University NHS Foundation Trust
Manchester
Ahmed Hassan
- Not yet recruiting
University Hospital Southampton NHS Foundation Trust
Southampton
Ewan Brownlee
- Not yet recruiting
Great Western Hospitals NHS Foundation Trust
Swindon
Amy Keightley
- Recruiting
Watford General Hospital
Watford
Paul Stanciu
About this study
Official title: 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.
- Conditions
- Robotic-assisted Soft-tissue Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Procedure related complication rates
Rate of total procedure related complications within 30 days and up to 12 months following surgery
Measured: Within 30 days and 12 months after surgery
Secondary outcomes (5)
Length of hospital stay
Hospital stay in days from day of surgery until discharge
Measured: 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
Proportion of surgical procedures requiring unplanned conversion to conventional laparoscopic or open surgery.
Measured: Up to completion of surgery
Operative time
Surgical time from skin incision to skin closure
Measured: Up to completion of surgery
Revision surgery rate
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.
Measured: Within 12 months following surgery
Rate of pre-defined index procedure specific complications
Percentage of participants who experience one or more pre-defined procedure-specific complications related to the index surgical procedure
Measured: Within 30 days and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start22 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic-assisted Soft-tissue SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMR Surgical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Paul Stanciu, Principal investigator, Watford General HospitalEwan Brownlee, Principal investigator, University Hospital Southampton NHS Foundation TrustAhmed Hassan, Principal investigator, Manchester University NHS Foundation TrustPankaj Mishra, Principal investigator, St Thomas' HospitalAmy Keightley, Principal investigator, Great Western Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761299
- Sponsor's protocol ID
- CA-00671
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Surgery With Versius in the NHS: Retrospective Comparative Performance Study Across Multiple Soft-Tissue Specialties
- ClinicalTrials.gov ID
- NCT07761299
- Acronym / sponsor ID
- CA-00671
- Conditions
- Robotic-assisted Soft-tissue Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- CMR Surgical LtdIndustry (pharma, biotech, devices)
- 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
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing soft-tissue surgical procedures using the Versius Surgical System or a comparator surgical approach (laparoscopic or open surgery).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Conversion rate
Time frame: Up to completion of surgery
Operative time
Time frame: Up to completion of surgery
Revision surgery rate
Time frame: Within 12 months following surgery
Rate of pre-defined index procedure specific complications
Time frame: Within 30 days and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Toderita contact
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic-assisted Soft-tissue Surgery, run by CMR Surgical Ltd at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Slack (+44 7766 024389, mark.slack@cmrsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure related complication rates (time frame: Within 30 days and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.