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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cervical Cancer; Gynecologic Cancer; Ovarian Cancer
• Intervention / Treatment: Device: Gynaecological laparoscopic surgery (Sirius System)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Wong Chuk Hang, Hong Kong
    • Gleneagles Hospital Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Gynaecological laparoscopic surgery; Eligible women aged 18 - 70 years, regardless of parity, who need laparoscopic gynaecological surgery and who provide informed consent prior to surgery

Device: Gynaecological laparoscopic surgery (Sirius System); The laparoscopic procedures were done in the usual manner. The only difference was for the study participants, the Sirius System was used in place of the usual conventional laparoscope. All other procedures and instruments including the number of ports remained the same. For every procedure using the Sirius System, a conventional laparoscope was on immediate standby to replace the Sirius System should there be an unanticipated equipment failure so that the procedure could be completed without delay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Assessment of SIRIUS Endoscope System.	General Assessment of SIRIUS Endoscope System, using Questionnaire- Clinical Study General Assessment of SIRIUS Endoscope System)	Through study completion, Up to 1 year from the first to the last patients
SIRIUS Endoscope Articulated tip assessment.	SIRIUS Endoscope Articulated tip assessment, using the Questionnaire -Clinical Study Assessment of SIRIUS Endoscope System Articulated Tip	Through study completion, Up to 1 year from the first to the last patients

Secondary Outcome Measures

Outcome Measure	Time Frame
The time of straight and bending positions of SIRIUS Endoscope System articulated tip	Through study completion, Up to 1 year from the first to the last patients
Events of device deficiency and/or malfunctions of SIRIUS Endoscope System	Through study completion, Up to 1 year from the first to the last patients
Intraoperative adverse events related to the SIRIUS Endoscope System	Through study completion, Up to 1 year from the first to the last patients
Postoperative complications related to the SIRIUS Endoscope System	Through study completion, Up to 1 year from the first to the last patients

Collaborators and Investigators

• Sponsor: Precision Robotics (Hong Kong) Limited
• Collaborators: Queen Mary Hospital, Hong Kong; Gleneagles Hospital
• Investigators: Principal Investigator: Tong Yow Ng, MD, Gleneagles Hospital

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PRHK02_TD8072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No