Plain English Summary
Background and study aims
CMR Surgical, a medical device company based in Cambridge, UK, has designed and built Versius, a new surgical robotic system. Surgeons use Versius to complete a laparoscopic surgical procedure (keyhole surgery) by sitting at the surgeon console, next to the patient in the operating room but away from the operating table. The surgeon looks at a screen and uses hand controllers to control the surgical instruments. At the bedside, small, wheeled carts (bedside units) are positioned by the operating room staff. Each bedside unit holds a robotic arm which either holds a camera or surgical instrument for the procedure. This type of surgery, where surgeons and operating room teams interact with Versius to complete an operation is sometimes known as robotically assisted surgery.
To monitor how safe Versius is for patients, CMR surgical has launched a surgical registry (the CMR Surgical Registry). The registry will also provide a database of how surgeons are using Versius. The registry will collect important information about every operation a surgeon performs using Versius. For example, the information will include what operation was carried out, how long it took, and how the patient recovered afterwards. CMR Surgical is asking every hospital and surgeon who uses Versius to take part in the registry and collect information from every operation they carry out. The registry is important to CMR Surgical because the company takes its responsibility for patient safety very seriously. By law, surgical device companies must monitor the safety of devices such as Versius. The company also wants to use the information in the registry to help them make changes to Versius and how surgeons use it - these changes may benefit patients in the future. CMR Surgical also wants to support and promote academic research to make robot-assisted surgery even safer.
Who can participate?
All patients eligible for surgery with Versius, as decided by the operating surgeon.
What does the study involve?
All potential participants will have surgery as usual and as decided by their healthcare professionals. To participate, the patient must agree that their surgeon can provide information to the registry, including information collected relevant to the operation in their medical records.
What are the possible benefits and risks of participating?
There are no direct benefits to individual patients by participating in the registry. The information collected may benefit patients in the future. There are no risks to providing information to the registry. Surgical risks will be explained by the surgeon and will be the same whether the patient participates in the information collection or not..
Where is the study run from?
CMR Surgical (UK)
When is the study starting and how long is it expected to run for?
January 2019 to April 2025
Who is funding the study?
CMR Surgical (UK)
Who is the main contact?
Mark Slack, registry@cmrsurgical.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Slack
ORCID ID
http://orcid.org/0000-0003-2176-8118
Contact details
CMR Surgical Ltd
Evolution Business Park
Impington
Cambridge
CB24 9NG
United Kingdom
01223755300
registry@cmrsurgical.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CMR Surgical Registry
Study information
Scientific title
CMR Surgical Registry
Acronym
Study hypothesis
The registry will enable post-market surveillance and safety monitoring of the Versius Surgical Robotic System, as well as record how surgeons use the system.
Ethics approval
The registry is a post-marketing surveillance database, collecting data about a new device used in routine clinical practice. It is not research and therefore does not require ethics approval.
Study design
Prospective, observational, multi-centred registry
Primary study design
Observational
Secondary study design
Registry
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional file (ISRCTN49651854_PIS_v5.0_17Sep2019)
Condition
Robot-assisted surgery, including urological, general laparoscopic and gynaecological laparoscopic surgical procedures
Intervention
The Versius Surgical Robotic System is licensed for use in urologic surgical procedures, general laparoscopic surgical procedures and gynaecologic laparoscopic surgical procedures. Peri-operative data will be collected from all consenting patients undergoing an operation performed with Versius by their surgeon or surgical team. Data will be collected from patient medical records at the time of surgery and up to 90 days post-operative follow-up. The registry has been designed to collect information that is commonly recorded in the peri-operative environment for all surgical procedures.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Intra- or post-operative complications recorded in the patient’s medical records up to 90 days post-surgery
Secondary outcome measures
1. Rate of conversion to another surgical method identified during surgery
2. Operative time recorded during surgery as recorded in patient medical records
3. Length of hospital stay as measured as time from admission to date of discharge recorded in patient medical records
4. Return to OR within 24 h as recorded in patient medical records
5. Readmission to hospital within 30 days as recorded in patient medical records
6. 90-day mortality as recorded in patient medical records
Overall trial start date
01/03/2019
Overall trial end date
30/04/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Any patient eligible for surgery using the Versius Surgical Robotic System as determined by their surgeon
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
all surgeries using Versius
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
02/03/2019
Recruitment end date
31/01/2025
Locations
Countries of recruitment
India
Trial participating centre
Deenanath Mangeshkar Hospital & Research Centre
c/o Dr Dhananjay Kelkar
Erandawne
Pune
Maharashtra
Pune
411004
India
Sponsor information
Organisation
CMR Surgical Limited
Sponsor details
Evolution Business Park
Impington
Cambridge
CB24 9NG
United Kingdom
01223755300
registry@cmrsurgical.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
CMR Surgical Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
CMR Surgical are committed to transparent communication of the analysis of registry data with planned publications in high-impact peer-reviewed journals. Where possible, cumulative analyses will be reported, with authors agreeing to abide by the International Committee of Medical Journal Editors (ICMJE) requirements.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from registry@cmrsurgical.com. Data requests will only be accepted from academics, clinicians or research institutions and will be assessed by the Clinical and Medical Affairs Team and independent Registry Steering Committee. Persons wishing to submit a request to access a dataset from the registry must provide a detailed project plan explaining which data is requested and for what reasons. Data may only be released once further anonymised, grouped, and evidence of ethics permission obtained. Data request functions will only be available from 2020.
Intention to publish date
01/06/2026
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN49651854_PIS_v5.0_17Sep2019.pdf uploaded 08/10/2019