Abstract
ObjectiveThe aim of this study was to provide an interim safety analysis of the first 30 surgical procedures performed using the Versius Surgical System.BackgroundRobot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is currently undergoing a first-in-human prospective clinical trial to confirm the safety and effectiveness of the device when performing minimal access surgery (MAS).MethodsProcedures were performed using Versius by a lead surgeon supported by an operating room (OR) team. Male or female patients aged between 18 and 65 years old and requiring elective minor or intermediate gynaecological or general surgical procedures were enrolled. The primary endpoint was the rate of unplanned conversion of procedures to other MAS or open surgery.ResultsThe procedures included nine cholecystectomies, six robot-assisted total laparoscopic hysterectomies, four appendectomies, five diagnostic laparoscopy cases, two oophorectomies, two fallopian tube recanalisation procedures, an ovarian cystectomy and a salpingo-oophorectomy procedure. All procedures were completed successfully without the need for conversion to MAS or open surgery. No patient returned to the OR within 24 h of surgery and readmittance rate at 30 and 90 days post-surgery was 1/30 (3.3%) and 2/30 (6.7%), respectively.ConclusionsThis first-in-human interim safety analysis demonstrates that the Versius Surgical System is safe and can be used to successfully perform minor or intermediate gynaecological and general surgery procedures. The cases presented here provide evidence that the Versius clinical trial can continue to extend recruitment and begin to include major procedures, in alignment with the IDEAL-D Framework Stage 2b: Exploration.
Highlights
This study reports the first-in-human use of Versius and aimed to (1) provide an initial safety analysis of 30 patients requiring minor or intermediate gynaecological or general surgery procedures, and (2) demonstrate system safety to support larger clinical trials [1, 22]
All cases were completed successfully. This first-in-human interim safety analysis demonstrates that Versius is safe and feasible for use in performing minor and intermediate gynaecological and general surgery procedures
This study shows promising first-in-human clinical trial data that support previous preclinical study results [18,19,20]
Summary
Procedures were completed at the Deenanath Mangeshkar Hospital and Research Center, Erandwane, Pune, Maharashtra 411004, India, between 6 March and 2 April 2019. This study was reviewed and approved by the Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Center. All study activities were performed in compliance with ICH Good Clinical Practice Schedule Y, Indian Council of Medical Research and ISO14511 standards. 65 years old and deemed suitable for at least one surgical procedure using Versius were enrolled. After being provided with relevant study information, patients provided written and audio-visual consent. In keeping with the requirements of the Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Center and in addition to the signed written consent, the consenting process was filmed and retained. For a full list of inclusion/exclusion criteria see Supplemental Table 1
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