First in-human trial and prospective case series of an articulated laparoscopic camera system in minimally invasive surgery in gynecology: an IDEAL stage 1 and 2a study.

OBJECTIVES

Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new, fully integrated, compact three-dimensional laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. This IDEAL Stage 1 and 2a study assessed its safety, reliability and potential efficacy particularly for single incision laparoscopic surgery and vaginal natural orifice transluminal endoscopic surgery.

DESIGN

Prospective single-institution, single-surgeon study.

SETTING

The study was conducted in a multispecialty hospital.

PARTICIPANTS

Women aged 18-70 years scheduled for gynecological laparoscopic surgery were invited to participate. An information sheet and consent was available for the women and an informed consent was obtained. Thirteen 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 conventional laparoscope. All other procedures and instruments remained the same.

MAIN OUTCOME MEASURES

Primary outcome was the proportion of women who successfully completed the intended procedure using the Sirius System without conversion to another camera system, camera users and surgeon's view and experience, and 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

85% (11/13) of women had their procedure completed successfully using the Sirius System. Two women required immediate conversion to the conventional laparoscope due to technical issues. There were no intraoperative complications. Users agreed that the improved field of view was beneficial for laparoscopic surgery. Iterative improvements were made in the imaging quality, user interface and manufacturing quality.

CONCLUSIONS

Sirius System has early indications for safety and efficacy for intermediate and major minimally invasive laparoscopic procedures in gynecology. Further studies are needed to confirm it can replace a conventional laparoscope in the surgical workflow.

TRIAL REGISTRATION NUMBER

NCT05048407.