Sirius in Gynaecological Laparoscopic Surgery

Precision Robotics

Status: Enrolling

Conditions: Gynecologic Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Device: Gynaecological laparoscopic surgery (Sirius System)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05048407

PRHK HKU-GHK IRB 2022-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Gynaecological laparoscopic surgery

Experimental group

Description:

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

Treatment:

Device: Gynaecological laparoscopic surgery (Sirius System)