Study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted total hysterectomy (a surgical procedure to remove your womb)

Prospective clinical study to evaluate the safety and efficacy of the Versius surgical system in robot-assisted total hysterectomy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68512297

Enrollment

Registered

2023-04-13

Start date

2023-05-01

Completion date

Unknown

Last updated

2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Robot-assisted total hysterectomy Surgery

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026