Successful Completion of Multi-Center, Multi-Specialty Clinical Trial
Ronovo Surgical successfully concluded its multi-center, multi-specialty clinical trial of the Carina™ RAS Platform in late February. This marks a significant milestone for the novel modular robotic system pioneered by an innovative medtech team based in Shanghai.
The final procedure of the clinical trial was completed by Prof. Taiyuan Li's team in the Department of General Surgery at the 1st Affiliated Hospital of Nanchang University. In addition to Prof. T. Li’s colorectal cohort, Ronovo had successively completed patient enrollment for urology, gynecology, and thoracic surgeries, collaborating with Prof. Dingwei Ye's team (urology) at Fudan University Shanghai Cancer Center, Prof. Mei Ji's team (gynecology) at the 1st Affiliated Hospital of Zhengzhou University, and Prof. Hecheng Li's team (thoracic) at Shanghai Jiaotong University’s Ruijin Hospital.
The culmination of the multi-center trial came only six months after the initial first-in-man clinical study. During this trial, the investigators successfully used Carina to perform up to five consecutive procedures per day, highlighting system’s safety, stability, and ease of use. The unanimous recognition and approval of these attributes by robotic surgery experts fueled the confidence and determination of the Ronovo team to complete trial enrollment in record time. This milestone also underlines another industry record-breaking achievement by the team – accelerating from concept design to completion of human clinical trials in under three years.
During these operations, Prof. Li demonstrated great proficiency in using Carina to smoothly perform maneuvers, such as separation, exposure, cutting, suturing, knotting, and hemostasis. In the middle of the colostomy during colorectal surgery, the advantages of Carina's split modular design were highlighted. There was no need to remove the bedside robotic arm cart, saving overall surgical time. The compact cart could be quickly removed postoperatively, optimizing the workflow of robotic surgery.
General surgery procedures typically involve extensive operations, placing higher demands on the robotic system's ability to operate across quadrants. Modular design offers more degrees of freedom for the robotic arms, which translates to greater operational space for surgeons, minimizing disruption during surgical operations, and better applying them in clinical practice for the benefit of patients.
On his positive experience with Carina during the clinical trial, Prof. Li commented, "Carina demonstrated fast response time and short overall operation time. The modular arms distributed bedside adapted well to our existing workflow, and placement of surgical ports was flexible. Whether it is a right hemicolectomy or a low anterior resection, Carina meets the surgical requirements very well."
Over the next three years, Ronovo established in-depth cooperation with over 30 surgical experts from China and abroad, who provided valuable input for optimizing clinical utility of Carina across various surgical specialties. With a focus on clinical engineering partnerships that drive R&D efforts, the company is continuously improving the performance of Carina to provide patients with safer and more precise surgical treatment.
