A database to record safety information from patients who have had surgery using the Versius Surgical Robotic System
| ISRCTN | ISRCTN49651854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49651854 |
| Secondary identifying numbers | CMR Surgical Registry |
- Submission date
- 11/09/2019
- Registration date
- 01/10/2019
- Last edited
- 26/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
CMR Surgical Ltd
Evolution Business Park
Impington
Cambridge
CB24 9NG
United Kingdom
 ORCID ID |
0000-0003-2176-8118 |
|---|---|
| Phone | 01223755300 |
| registry@cmrsurgical.com |
Study information
| Study design | Prospective, observational, multi-centred registry |
|---|---|
| Primary study design | Observational |
| Secondary study design | Registry |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN49651854_PIS_v5.0_17Sep2019.pdf |
| Scientific title | CMR Surgical Registry |
| Study objectives | Current study hypothesis as of 26/01/2021: The registry will enable post-market surveillance and safety monitoring of the Versius Surgical Robotic System. Previous 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(s) | 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. |
| Health condition(s) or problem(s) studied | Robot-assisted surgery, including urological, general, gynaecological, and thoracic laparoscopic surgical procedures |
| Intervention | Current interventions as of 26/01/2021: The Versius Surgical Robotic System is licensed for use in urologic surgical procedures, general laparoscopic surgical procedures, gynaecologic laparoscopic surgical procedures and thoracic 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. Previous interventions: 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/03/2019 |
| Completion date | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | All surgeries using Versius |
| Key inclusion criteria | Any patient eligible for surgery using the Versius Surgical Robotic System as determined by their surgeon |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 02/03/2019 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- England
- France
- India
- Scotland
- United Kingdom
Study participating centres
Erandawne
Pune
Maharashtra
Pune
411004
India
Nashik
422002
India
Edinburgh
EH4 2XU
United Kingdom
Milton Keynes
MK6 5LD
United Kingdom
Sponsor information
Industry
Evolution Business Park, Impington
Cambridge
CB24 9NG
United Kingdom
| Phone | 01223755300 |
|---|---|
| registry@cmrsurgical.com | |
| Website | www.cmrsurgical.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v5.0 | 17/09/2019 | 08/10/2019 | No | Yes |
Additional files
- ISRCTN49651854_PIS_v5.0_17Sep2019.pdf
- uploaded 08/10/2019
Editorial Notes
26/01/2021: The following changes were made to the trial record:
1. The study hypothesis and interventions were updated.
2. The condition was changed from "Robot-assisted surgery, including urological, general laparoscopic and gynaecological laparoscopic surgical procedures" to "Robot-assisted surgery, including urological, general, gynaecological, and thoracic laparoscopic surgical procedures".
3. France and UK were added to the countries of recruitment.
4. Western General Hospital and Milton Keynes University Hospital were added to the trial participating centres.
19/03/2020: The trial participating centre "HCG Manavata Cancer Centre" was added.
08/10/2019: The participant information sheet has been uploaded as an additional file.
