A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
NCT ID: NCT05318625
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-01-10
2024-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patient is 18 years of age or older
* Signed written informed consent.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Gleneagles Hospital
OTHER
Queen Mary Hospital, Hong Kong
OTHER
Precision Robotics (Hong Kong) Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Tong Yow Ng, MD
Role: PRINCIPAL_INVESTIGATOR
Gleneagles Hospital
Locations
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Gleneagles Hospital Hong Kong
Wong Chuk Hang, , Hong Kong
Countries
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Related Links
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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
Other Identifiers
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PRHK02_TD8072
Identifier Type: -
Identifier Source: org_study_id
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