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 | ISRCTN11414606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11414606 |
| Secondary identifying numbers | CA-00361 |
- Submission date
- 27/10/2022
- Registration date
- 03/11/2022
- Last edited
- 28/10/2022
- 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 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 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 a console to control a set of robotic arms which are holding instruments needed to perform minimal access surgery.
Who can participate?
All non-pregnant female patients aged 18 years and above, eligible for 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. The risks from participating in this study are similar to those associated with any minimal access (keyhole) womb removal surgical procedure.
Where is the study run from?
CMR Surgical (UK)
When is the study starting and how long is it expected to run for?
March 2022 to March 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
HCG Manavata Cancer Centre
Nashik
Mumbai Naka
Mumbai
422002
India
| Phone | +91 98230 61929 |
|---|---|
| drraj@manavatacancercentre.com |
Scientific
Navelcar Pride, Ground Floor, Department of Clinical Operations
Kadamba Plateau, NH4A
Chimbel
Tiswadi
Goa
403006
India
| Phone | +91 96232 43509 |
|---|---|
| manisha.jadhav@cmrsurgical.com |
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 | V.C.S.-TLH |
| Study objectives | The Versius surgical system is safe and efficacious in performing robot-assisted total hysterectomies |
| Ethics approval(s) | Approved 11/08/2022, Manavata Clinical Research Institute Ethics Committee (Mumbai Naka, Nashik-422002, India; +91 253-6661111; mpec.nashik@gmail.com), ref: ECR/500/Inst/MH/2013-RR20 |
| 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 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 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 patient’s medical records 5. Return to 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 recoded by surgeon on medical records at the clinic on 42 days post operative follow up 11. Histopathology results of any surgically removed specimens from medical records available at day of discharge and at 30 day 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 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 | 01/03/2022 |
| Completion date | 31/03/2023 |
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 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. Female, aged 18 years or above 4. Female 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 >11mmol/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, lifethreatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure 12. Patient tested COVID positive within last 30 days of screening 13. Patient tested COVID positive within 48 hours within procedure |
| Date of first enrolment | 17/11/2022 |
| Date of final enrolment | 01/01/2023 |
Locations
Countries of recruitment
- India
Study participating centre
Mumbai Naka
Nashik
Maharashtra
Mumbai
422002
India
Sponsor information
Industry
194 Cambridge Science Park
Milton Road
Cambridge
CB4 0AB
England
United Kingdom
| Phone | +44 1223 755300 |
|---|---|
| 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 | 15/11/2023 |
|---|---|
| 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. 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
28/10/2022: Trial's existence confirmed by Manavata Clinical Research Institute Ethics Committee.
