Versius clinical study to evaluate the safety and performance of the Versius Surgical Robotic System

Phase 2

• Conditions: Robotically assisted surgery in patients requiring general, gynaecological, urological and colorectal surgical and minimal access procedures; Surgery

• Registration Number: ISRCTN74522039
• Lead Sponsor: CMR Surgical (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-25
• Last Update Posted: 7 September 2021
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 645

Inclusion Criteria

1. Patient deemed suitable for at least one of the surgical procedures using Versius
2. Patients (or appropriate legal representatives) able to provide written and audio-visual informed consent to participate in the study
3. Male or female aged between 18 and 65 years old
4. If female of childbearing potential, must not be pregnant and agree to not become pregnant for the duration of the study

Exclusion Criteria

1. Patient participation in an investigational clinical study within 30 days before screening
2. Inability to provide informed consent
3. Uncontrolled hypertension (=/>systolic: 180 mmHg/diastolic: 120 mmHg) and/or diabetes mellitus (blood sugar level: >200 mg/dl)
4. Patients who fall into American Society of Anesthesiologists (ASA) Class IV
5. History of chronic alcohol or drug abuse
6. Chronic renal failure or on dialysis
7. Significant medical history or immunocompromised and/or chronic use of systemic steroids
8. Patients undergoing surgery or treatment for malignant disease
9. Subjects with any other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contraindicate a surgical procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary effectiveness outcome:<br> Rate of conversion to other laparoscopic or open surgery intraoperatively, as recorded on the data entry platform by the surgeon<br><br> Primary safety outcome:<br> 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 90 days after surgery)<br>