Sirius in Gynaecological Laparoscopic Surgery

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: Recruiting
• 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 Contact: Name: Benny Lo, PhD; Phone Number: +852 64785586; Email: b.lo@precisionrobotics.com
• Study Contact Backup: Name: Ruchita Mehta, MS; Phone Number: +852 70734437; Email: R.Mehta@precisionrobotics.com

Study Locations

• Hong Kong
  • Wong Chuk Hang, Hong Kong
    • Recruiting
    • Gleneagles Hospital Hong Kong
    • Contact: Tong Yow Ng, Dr.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Eligible women, 18 or older, who are planned for laparoscopic gynaecological surgery and willing to provide informed consent prior to surgery

Exclusion Criteria:

1. Patient is pregnant, or planning on becoming pregnant
2. Obese patients (BMI >35)
3. Patient with known contraindication(s) to Laparoscopic Gynecological Surgery
4. Patient with operations planned for longer than 4 hours
5. 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
To evaluate the Performance and Safety of the SIRIUS Endoscope System articulated tip.	The performance and safety of the endoscope system will be evaluated based on the outcome of the operation, in terms of patient blood lost and duration of the operation are comparable with the use of other conventional endoscope systems.	Data will be collected during the operation and the analysis will be completed up to 1 month post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the amount of time of straight and bending positions of SIRIUS Endoscope System articulated tip. To evaluate the events of device deficiency and/or malfunctions of SIRIUS Endoscope System. To evaluate the Safety of SIRIUS Endoscope System	To assess the effectiveness of the bending function of the SIRIUS endoscope system by capturing the amount of time the SIRIUS endoscope is bent or straightened during the operation.	Data will be collected during the operation and it will be completed upon the completion of the operation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Ng TY, Ngu SF, Kam TYD, Ng SY, Lo PLB. 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. BMJ Surg Interv Health Technol. 2022 Mar 4;4(1):e000117. doi: 10.1136/bmjsit-2021-000117. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PRHK HKU-GHK IRB 2022-02

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