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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05318625
• Other study ID #: PRHK02_TD8072
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Precision Robotics (Hong Kong) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Gynecologic Cancer
• Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Gleneagles Hospital Hong Kong	Wong Chuk Hang

Sponsors (3)

Lead Sponsor	Collaborator
Precision Robotics (Hong Kong) Limited	Gleneagles Hospital, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Intraoperative adverse events related to the SIRIUS Endoscope System		Through study completion, Up to 1 year from the first to the last patients
Secondary	Postoperative complications related to the SIRIUS Endoscope System		Through study completion, Up to 1 year from the first to the last patients

External 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