Prospective case series of an articulated laparoscopic camera system in minimally invasive surgery in gynaecology: an IDEAL stage 2a study

Objectives Precision Robotics’ Sirius Robotic Flexible Endoscopic System is a new fully integrated compact laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. The aim of this Idea, Development, Exploration, Assessment, Long-term follow-up stage 2a study was to assess its clinical performance and safety. Design Prospective multi-institution, multisurgeon study. Setting The study was conducted in two multispecialty hospitals. Participants Women aged 18–70 years scheduled for gynaecological laparoscopic surgery were invited to participate. An information sheet and consent form were available for the women and an informed consent was obtained. Twenty-five participants completed this study. Interventions The laparoscopic procedures were done in the usual manner. The only difference was the Sirius system was used in place of the usual conventional laparoscope. All other procedures and instruments including the number of ports used remained the same. Main outcome measures Primary outcome was camera users and surgeon’s view and experience; iterations and modifications to the system. Secondary outcomes were the incidence of intraoperative and postoperative complications during the first 6 weeks following surgery and duration of surgery. Results 100% (25/25) of women had their procedure completed successfully using the Sirius System. There were no intraoperative complications. The median operating time was 68 min (range: 32–257 min). Users agreed that the improved field of view was beneficial for laparoscopic surgery. Iterative improvements were made in the user interface and manufacturing quality. Conclusions The study demonstrated stability and safety of the Sirius System across different institutions and teams for intermediate and major minimally invasive laparoscopic procedures in gynaecology. Further studies are needed to confirm it can replace a conventional laparoscope in the surgical workflow. Trial registration NCT05048407 .