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

August 2, 2023 updated by: Precision Robotics (Hong Kong) Limited

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: Through study completion, Up to 1 year from the first to the last patients
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.
Time Frame: Through study completion, Up to 1 year from the first to the last patients
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
Time Frame: Through study completion, Up to 1 year from the first to the last patients
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
Time Frame: Through study completion, Up to 1 year from the first to the last patients
Through study completion, Up to 1 year from the first to the last patients
Intraoperative adverse events related to the SIRIUS Endoscope System
Time Frame: Through study completion, Up to 1 year from the first to the last patients
Through study completion, Up to 1 year from the first to the last patients
Postoperative complications related to the SIRIUS Endoscope System
Time Frame: Through study completion, Up to 1 year from the first to the last patients
Through study completion, Up to 1 year from the first to the last patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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