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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74522039

Enrollment

645

Registered

2021-08-25

Start date

2019-03-04

Completion date

Unknown

Last updated

2021-09-07

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

Conditions

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

Interventions

The Versius Surgical Robotic System is used for robotic-assisted surgeries in the fields of: 1. General surgery – cholecystectomy, appendectomy, bilateral inguinal hernia (TAPP), gastr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary effectiveness outcome: Rate of conversion to other laparoscopic or open surgery intraoperatively, as recorded on the data entry platform by the surgeon 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 90 days after surgery)	—

Measure

Time frame

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

—

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. Return to operating room within 24 hours after surgery, measured using medical records 5. Length of hospital stay in days (from date of procedure to date of discharge), measured using medical records 6. Incidence of readmission to hospital within 30 days after surgery, measured using medical records and 30-day follow-up calls/visit 7. Any intra-operative complications during surgery collected as procedural data and from patient’s medical records 8. Postoperative complications reported using Clavien-Dindo Classification up to 90 days 9. 90-day mortality from medical records and/or follow-up visit/call during the 90-day follow up	—

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. Return to operating room within 24 hours after surgery, measured using medical records 5. Length of hospital stay in days (from date of procedure to date of discharge), measured using medical records 6. Incidence of readmission to hospital within 30 days after surgery, measured using medical records and 30-day follow-up calls/visit 7. Any intra-operative complications during surgery collected as procedural data and from patient’s medical records 8. Postoperative complications reported using Clavien-Dindo Classification up to 90 days 9. 90-day mortality from medical records and/or follow-up visit/call during the 90-day follow up

—

Countries

India

Contacts

Public ContactManisha Jadhav

manisha.jadhav@cmrsurgical.com+91 (0)9623243509

Outcome results

None listed

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