On the Versius Surgical Robot System, the next-generation surgical robot system, CMR Surgical Ltd today announced that it has successfully completed its first series of surgical procedures in humans.
Thirty laparoscopic procedures were completed as part of a clinical trial at Deenanath Mangeshkar Hospital & Research Center in Pune, India, by Consultant Oncologist and General Surgeon Dr. Dhananjay Kelkar and his team. The surgeries consisted of minor, intermediate and major gynaecological and upper gastrointestinal (GI) procedures. No adverse events were reported as a result of the use of Versius robot system after a 30 day follow up.
On the Versius Surgical Robotic System, Dr. Dhananjay Kelkar commented, “As the first surgeon to conduct a laparoscopic procedure in a clinical setting using Versius, I can say that the system has been shown to be highly effective and has significant potential for bringing minimal access surgery to patients here in India, and around the world. The Versius Surgical Robotic System is flexible and fits easily into our busy operating environment.” “We have a high demand for surgical care and are committed to bringing the most innovative technologies to our patients,” concluded Dr. Kelkar.
“This first-in-human series is a significant milestone in bringing Versius to operating theatres around the world. These initial results are positive and we look forward to further advancing our mission to bring the benefits of minimal access surgery to everyone who needs it. This series is part of our drive for the responsible introduction of surgical robotic systems that puts safety and effectiveness above all else,” commented Mark Slack, Chief Medical Officer at CMR Surgical.
The clinical trial was conducted in line with CMR Surgical’s collaboration with the IDEAL framework which provides an international benchmark for each stage of the surgical innovation process, including clinical trials. The first-in-human series is being carried out under internationally recognized clinical trial protocols as set out by Good Clinical Practice (GCP).
The company received a European CE Mark in March for the Versius® Surgical Robotic System.
Following the completion of the first-in-human series, CMR Surgical will work closely with surgeons and hospitals on a clinical introduction of the Versius Surgical Robotic System to bring the benefits of minimal access surgery to patients around the world.
The Versius Clinical Study is a single-centre, prospective cohort study. The study design is to evaluate the safety and performance of Versius in robotically-assisted surgery across a range of abdominal and pelvic surgical procedures. The primary endpoint of the study is the rate of unplanned conversion of procedures to other minimal access surgery or open surgery. Secondary outcomes collected are, operative time; estimated blood loss and blood transfusion rate, intra-operative complications; return to operating room within 24 hours; length of hospital stay; and readmission to hospital within 30 days of surgery. Ninety-day mortality statistics will be collected. The performance of Versius will be assessed continuously throughout the study and any problems with the system will be monitored and reported.
The results of this study will be included in the CMR Surgical Registry. This is a prospective real-world data registry, set up to gather clinical performance and safety data on all surgical procedures conducted with the Versius® Surgical System in all geographical locations. In addition to providing post-market safety data it will also allow monitoring of individual surgical performance.