Squamous Cell Carcinoma of the OropharynxNCT06112535
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
A study testing Versius Surgical System in people with Squamous Cell Carcinoma of the Oropharynx and Squamous Cell Carcinoma, Unknown Primary, run by CMR Surgical Ltd at 1 site in United Kingdom.
Trial summary
This is a single-arm, single site, multi-surgeon prospective feasibility 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma, Unknown Primary
- What is being tested?
- Versius Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Dec 2023to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient and disease factors deemed suitable for Robotic-Assisted Trans Oral Robotic Surgery (TORS) procedure using the Versius Surgical System
- Aged 18 or over with signed, written informed consent
- Histologically confirmed squamous cell carcinoma of the oropharynx {UICC/AJCC TNM (7) stage T1-3, N0-N2b / TNM (8) T1-3, N0-1 disease} OR Histologically confirmed squamous cell carcinoma in 1 or more cervical lymph nodes, with no discernible primary tumour (cancer unknown primary)
- Patients considered fit for surgery and potential adjuvant treatment (WHO performance status 0-2)
- Multidisciplinary team (MDT) decision to treat with primary surgery
- Surgical site and anatomical factors allowing access and freedom of operating using Versius Surgical System
Who cannot join
- T4 tumours, or T1-T3 where transoral surgery is not considered feasible due to anatomy, location, or disease factors; these may include (but not limited to) tumour visualisation, endophytic growth pattern and resulting defect functional concerns
- Disease / anatomical factors limiting access and freedom of operating using Versius Surgical System
- Patients with distant metastatic disease as determined by pre-operative staging
- UICC/AJCC TNM (7) stage N2c-N3 disease; TNM (8) N2-3 disease
- American Society of Anaesthesiologists (ASA) Class IV or above
- WHO Performance status 3 or above
Show all 12Show fewer
- Unwilling or unable to sign an informed consent form
- Morbid Obesity (BMI ≥40)
- Active pregnancy
- Medical Contraindication for general anaesthesia
- Patient participation in an interventional clinical study within 30 days prior to screening, and up to 45 days post-surgery
- Patients with a history of radiotherapy to the head or neck
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust
Liverpool, L9 7AL
About this study
This is a single-arm, single site, multi-surgeon prospective feasibility 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. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).
- Being tested
- Versius Surgical System
- Keywords
- TORS, robotic surgery, transoral robotic surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Versius Surgical SystemDevice
Transoral robotic surgery (TORS) using Versius Surgical System. Versius is a robot designed to help surgeons perform surgery. It consists of a set of robotic arms: one of the arms has a camera and a light source on it while the other arms each have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them, while seeing the surgical area on a screen in front of him/her.
The camera and instruments are inserted into the mouth and throat in order to cut out a cancerous tumour.
| Study group | Role | What they receive |
|---|---|---|
| TORS with Versius | Experimental | Not described Receives: Device: Versius Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Adverse Events
To assess safety of TORS with Versius
Measured: Up to 30 days post operatively
Rate of successful completion of TORS without conversion
To assess efficacy of TORS with Versius by the rate of successful completion of Transoral Robotic Surgery (TORS) without unplanned conversion to other transoral or open techniques
Measured: Up to completion of surgery
Secondary outcomes (9)
Operative time
Time taken to complete surgery, excluding any reconstruction
Measured: Up to completion of surgery
Incidence of Serious Adverse Events
Incidence of Serious Adverse Events
Measured: Up to 30 days post operatively
Blood loss
Estimated blood loss during surgery
Measured: Up to completion of surgery
Post-operative analgesic requirements in morphine equivalents
Pain medication taken post-surgery converted to morphine equivalents
Measured: Up to post-surgery discharge (up to 30 days post-surgery)
Length of stay
Length of post operative stay in hospital
Measured: Up to discharge (up to 30 days post-surgery)
Reoperation
Emergency re-operation after initial surgery
Measured: Up to 30 days post operatively
Device deficiencies and user errors
Device deficiencies and user errors
Measured: Up to completion of surgery
Return to oral intake
Amount of time after surgery before oral intake, including nasogastric tube requirement and length of use
Measured: Up to post-surgery discharge (up to 30 days post-surgery)
Pathological margin
Final pathological margin of resected specimens (mm)
Measured: Up to 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start13 Dec 2023
- Primary completion16 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the OropharynxStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMR Surgical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust, Sintesi Research Srl
- Responsible party
- Sponsor
- Investigators
- Jason Fleming, MD PhD, Principal investigator, ENT Department Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112535
- Sponsor's protocol ID
- CA-00388
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2023
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
- ClinicalTrials.gov ID
- NCT06112535
- Acronym / sponsor ID
- CA-00388
- Keywords
- TORS, robotic surgery, transoral robotic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CMR Surgical LtdIndustry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust, Sintesi Research Srl
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 1 Nov 2023 (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.
This is a single-arm, single site, multi-surgeon prospective feasibility 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. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TORS with Versius | Experimental | Device: Versius Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient and disease factors deemed suitable for Robotic-Assisted Trans Oral Robotic Surgery (TORS) procedure using the Versius Surgical System
- Aged 18 or over with signed, written informed consent
- Histologically confirmed squamous cell carcinoma of the oropharynx {UICC/AJCC TNM (7) stage T1-3, N0-N2b / TNM (8) T1-3, N0-1 disease} OR Histologically confirmed squamous cell carcinoma in 1 or more cervical lymph nodes, with no discernible primary tumour (cancer unknown primary)
- Patients considered fit for surgery and potential adjuvant treatment (WHO performance status 0-2)
- Multidisciplinary team (MDT) decision to treat with primary surgery
Key exclusion criteria (12 listed)
- T4 tumours, or T1-T3 where transoral surgery is not considered feasible due to anatomy, location, or disease factors; these may include (but not limited to) tumour visualisation, endophytic growth pattern and resulting defect functional concerns
- Disease / anatomical factors limiting access and freedom of operating using Versius Surgical System
- Patients with distant metastatic disease as determined by pre-operative staging
- UICC/AJCC TNM (7) stage N2c-N3 disease; TNM (8) N2-3 disease
- American Society of Anaesthesiologists (ASA) Class IV or above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Versius Surgical SystemTransoral robotic surgery (TORS) using Versius Surgical System. Versius is a robot designed to help surgeons perform surgery. It consists of a set of robotic arms: one of the arms has a camera and a light source on it while the other arms each have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them, while seeing the surgical area on a screen in front of him/her. The camera and instruments are inserted into the mouth and throat in order to cut out a cancerous tumour. | Device | TORS with Versius |
Primary outcome
Incidence rate of Adverse Events
Time frame: Up to 30 days post operatively
To assess safety of TORS with Versius
Rate of successful completion of TORS without conversion
Time frame: Up to completion of surgery
To assess efficacy of TORS with Versius by the rate of successful completion of Transoral Robotic Surgery (TORS) without unplanned conversion to other transoral or open techniques
9 secondary outcomes
Operative time
Time frame: Up to completion of surgery
Incidence of Serious Adverse Events
Time frame: Up to 30 days post operatively
Blood loss
Time frame: Up to completion of surgery
Post-operative analgesic requirements in morphine equivalents
Time frame: Up to post-surgery discharge (up to 30 days post-surgery)
Length of stay
Time frame: Up to discharge (up to 30 days post-surgery)
Reoperation
Time frame: Up to 30 days post operatively
Device deficiencies and user errors
Time frame: Up to completion of surgery
Return to oral intake
Time frame: Up to post-surgery discharge (up to 30 days post-surgery)
Pathological margin
Time frame: Up to 30 days post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- 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. This study is not recruiting at the moment.
Jason Fleming, MD PhD principal investigator
ENT Department Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Versius Surgical System in people with Squamous Cell Carcinoma of the Oropharynx and Squamous Cell Carcinoma, Unknown Primary, run by CMR Surgical Ltd at 1 site 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of Adverse Events (time frame: Up to 30 days post operatively). The study lists 2 primary outcomes in all. 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 25 Jun 2025.