Study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted total hysterectomy (a surgical procedure to remove your womb)
| ISRCTN | ISRCTN68512297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68512297 |
| Secondary identifying numbers | CA-00374 |
- Submission date
- 13/04/2023
- Registration date
- 13/04/2023
- Last edited
- 13/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Minimal access surgery (also known as keyhole surgery) has been carried out for over 30 years at hospitals around the world. It is well-established and has several advantages over other surgical methods, such as a shorter recovery time, fewer complications and a shorter hospital stay. Thousands of minimal access operations are carried out each year. Recently it has been possible to use robot arms to help carry out minimally invasive operations.
This study is being run to assess the safety and competence of the Versius® Surgical Robotic System in performing operations for the removal of the womb in females. Versius is a robot designed to be used in minimal access surgery. It has been developed and built by CMR Surgical Limited, a UK-based and registered company. The system allows a surgeon to stand or sit at a console to control a set of robotic arms which are holding instruments needed to perform minimal access surgery.
Who can participate?
Non-pregnant female patients aged 18 years and above who are eligible for womb removal surgery with Versius, as decided by the operating surgeon
What does the study involve?
All participants will have womb removal surgery as usual and as decided by their healthcare professionals.
What are the possible benefits and risks of participating?
There are no direct benefits to participants. The information collected may benefit patients in the future, however, the expected benefits of surgery with Versius include a minimized risk of injury due to improved surgical precision, a lower risk of infection, bleeding and pain, earlier discharge from hospital and smoother recovery, compared to open surgery. The risks of participating in this study are similar to those associated with any minimal access (keyhole) womb removal surgical procedure and will be explained in detail before surgery.
Where is the study run from?
CMR Surgical (UK)
When is the study starting and how long is it expected to run for?
July 2022 to November 2023
Who is funding the study?
CMR Surgical (UK)
Who is the main contact?
Dr Mark Slack, mark.slack@cmrsurgical.com
Contact information
Principal Investigator
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu
Medycznego w Katowicach, Medyków 14
Katowice
40-572
Poland
 ORCID ID |
0000-0003-1079-8143 |
|---|---|
| Phone | +32 (0)7894726 |
| knowosielski@sum.edu.pl |
Study information
| Study design | Prospective non-randomized single-arm clinical trial cohort |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prospective clinical study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted total hysterectomy |
| Study acronym | VCSTLH-Poland |
| Study objectives | The Versius surgical system is safe and efficacious in performing robot-assisted total hysterectomies |
| Ethics approval(s) | Approved 18/10/2022, Ethics Committee of The Medical University of Silesia in Katowice (Ul. Poniatowskiego 15, 40-055 Katowice, Poland; +48 (0)322083546; kombioet@sum.edu.pl), ref: PCN/CBN/0052/KB1/100/I/22 |
| Health condition(s) or problem(s) studied | Robot-assisted total hysterectomy |
| Intervention | A prospective single-arm cohort study for robot-assisted total hysterectomies with the Versius Surgical Robotic System. Use of Versius, patient care and all follow-ups (up to day 42 +/-2 days) will be as per standard clinical practice, and Good Clinical Practice (GCP) and regulatory requirements will be strictly followed. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Versius Surgical Robotic System |
| Primary outcome measure | Primary safety outcome: Incidence of serious adverse events, recorded on the data entry platform at any time between commencement of surgery (intraoperative) to the end of the trial (postoperative, between the incidence of surgery to 30 days after surgery) Primary efficacy outcome: Rate of successful completion of robot-assisted surgery without unplanned conversion to other laparoscopic or open surgery, as recorded on the data entry platform |
| Secondary outcome measures | 1. Operative time measured in minutes from incision to skin closure at the facility, collected as procedural data from medical records 2. Estimated blood loss (in ml) during surgery, collected as procedural data from medical records 3. Blood transfusion during surgery (number of blood transfusion products used [if any]) collected from patient’s medical records 4. Any intra-operative complications during surgery collected as procedural data and from the patient’s medical records 5. Return to the operating room within 24 hours after surgery, measured using medical records 6. Length of hospital stay in days (from date of procedure to date of discharge), measured using medical records 7. Incidence of readmission to hospital within 30 days after surgery, measured using medical records and at 30-day follow-up 8. Incidence of reoperation within 30 days after surgery, measured using medical records and at 30-day follow-up 9. 30-day mortality from medical records and/or follow-up visit/call during the 30-day follow up 10. Vaginal vault healing, as assessed and recorded by the surgeon on medical records at the clinic on 42 days postoperative follow-up 11. Histopathology results of any surgically removed specimens from medical records available on the day of discharge and at 30 days follow up 12. Incidence of device deficiencies and use errors regardless of relationship to an adverse event, collected as procedural and/or adverse event data and from patient medical records, between intraoperative period until discharge 13. All adverse events, including postoperative complications reported using Clavien-Dindo Classification and according to medical records, up to 30 days' follow up 14. Device performance data including unplanned instrument usage, clashes, collision detection, alarms, collected as procedural data during surgery |
| Overall study start date | 01/07/2022 |
| Completion date | 01/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Patient deemed suitable for total laparoscopic hysterectomy procedure using the Versius Surgical Robotic System 2. Patients able to provide written informed consent to participate in the study (with help of appropriate legal representatives if required) 3. Females aged 18 years or above 4. Females of childbearing potential must not be pregnant 5. Patients with BMI ≤40 kg/m². Ideally BMI ≥25 to ≤40 kg/m² |
| Key exclusion criteria | 1. Patient participation in an investigational clinical study within 30 days before screening 2. Inability or difficulties to provide informed consent 3. Uncontrolled hypertension (≥systolic: 180 mmHg/diastolic: 120 mmHg) 4. Diabetes mellitus (glycemia >11 mmol/l; >200 mg/dl) 5. Oncological cases, patients undergoing surgery or treatment for malignant disease 6. Patients who fall into American Society of Anaesthesiologists (ASA) Class IV or above 7. Uterus size of >14 weeks 8. History of chronic alcohol or drug abuse 9. Chronic renal failure or on dialysis 10. Significant medical history or immunocompromised 11. Subjects with any other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure 12. Patient tested COVID positive within the last 30 days of screening 13. Patient tested COVID positive within 48 hours of the procedure |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 01/09/2023 |
Locations
Countries of recruitment
- Poland
Study participating centre
Katowice
40-572
Poland
Sponsor information
Industry
1 Evolution Business Park
Milton Road
Cambridge
CB24 9NG
England
United Kingdom
| Phone | +44 (0)7766 024389 |
|---|---|
| customer.service@cmrsurgical.com | |
| Website | https://cmrsurgical.com/ |
"ROR" |
https://ror.org/00nq5xx94 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 10/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in peer-reviewed journals and according to the EU Clinical Trials Regulations (CTR). The researchers are not planning on making the protocol publicly available at this time. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
13/04/2023: Trial's existence confirmed by the Ethics Committee of The Medical University of Silesia in Katowice.
