A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

  • STATUS
    Recruiting
  • End date
    Jul 14, 2023
  • participants needed
    30
  • sponsor
    Precision Robotics (Hong Kong) Limited
Updated on 4 October 2022

Summary

Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.

A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

The study is a single-arm prospective study to evaluate the Performance and Safety of the SIRIUS Endoscope System.

Description

Minimally invasive surgery (MIS) is well established in gynecological surgery. Compared to laparotomy, MIS is associated with reduced morbidity and quicker recovery. With advancement in laparoscopic technology and techniques, MIS in gynecology has progressed from multi-port to single incision laparoscopic surgery (SILS) and vaginal natural orifice transluminal endoscopic surgery (vNOTEs), thus further reducing morbidity and enhancing recovery.

One of the challenges of MIS is the restriction of the range of surgical movement. To overcome these technical challenges, articulated instruments are increasingly being used. The SIRIUS Endoscope System is a new, fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. The articulated tip has three degrees of freedom, enabling C and S-shaped bending, and providing a wider field of view compared to conventional laparoscopes. This wider field of view is of advantage for SILS and vNOTEs. Presently available commercial systems do not have the same field of view or degrees of freedom.

A first in-human, proof of concept, and early development study of the SIRIUS Endoscope System was done at GHK in 2021 (HKU-GHK IRB 2021-01, ClinicalTrials.gov NCT05048407). The successful completion of 11 of 13 (85%) planned procedures in this sequentially reported, prospective case series, shows that the SIRIUS Endoscope System can be used with indications of safety, and efficacy for intermediate and major MIS laparoscopic procedures in gynecology. The findings have been submitted for consideration for publication.

Based on the outcome of this study, further improvements to the SIRIUS Endoscope System have been made to enhance safety, reliability, and usability. This proposed prospective study is a confirmatory study to evaluate the performance and safety of the SIRIUS Endoscope System in preparation for regulatory approval.

Details
Condition Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
Treatment Gynaecological laparoscopic surgery (Sirius System)
Clinical Study IdentifierNCT05318625
SponsorPrecision Robotics (Hong Kong) Limited
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who are planned for Laparoscopic Gynecological Surgery (LGS)
Patient is 18 years of age or older
Signed written informed consent

Exclusion Criteria

Patient is pregnant, or planning on becoming pregnant
Obese patients (BMI >35)
Patient with known contraindication(s) to Laparoscopic Gynecological Surgery
Patient with operations planned for longer than 4 hours
Subjects are considered ineligible for the study as judged by the investigator
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