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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05318625
Other study ID # PRHK02_TD8072
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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