Ovarian CancerNCT05318625
A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
A study testing Gynaecological laparoscopic surgery (Sirius System) in people with Ovarian Cancer and Cervical Cancer, run by Precision Robotics (Hong Kong) Limited at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
- What is being tested?
- Gynaecological laparoscopic surgery (Sirius System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jan 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are planned for Laparoscopic Gynecological Surgery (LGS)
- Patient is 18 years of age or older
- Signed written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
- Being tested
- Gynaecological laparoscopic surgery (Sirius System)
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynaecological laparoscopic surgery (Sirius System)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Gynaecological laparoscopic surgery | Experimental | Eligible women aged 18 - 70 years, regardless of parity, who need laparoscopic gynaecological surgery and who provide informed consent prior to surgery Receives: Device: Gynaecological laparoscopic surgery (Sirius System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Assessment of SIRIUS Endoscope System.
General Assessment of SIRIUS Endoscope System, using Questionnaire- Clinical Study General Assessment of SIRIUS Endoscope System)
Measured: Through study completion, Up to 1 year from the first to the last patients
SIRIUS Endoscope Articulated tip assessment.
SIRIUS Endoscope Articulated tip assessment, using the Questionnaire -Clinical Study Assessment of SIRIUS Endoscope System Articulated Tip
Measured: Through study completion, Up to 1 year from the first to the last patients
Secondary outcomes (4)
The time of straight and bending positions of SIRIUS Endoscope System articulated tip
Measured: 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
Measured: Through study completion, Up to 1 year from the first to the last patients
Intraoperative adverse events related to the SIRIUS Endoscope System
Measured: Through study completion, Up to 1 year from the first to the last patients
Postoperative complications related to the SIRIUS Endoscope System
Measured: Through study completion, Up to 1 year from the first to the last patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start10 Jan 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Robotics (Hong Kong) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gleneagles Hospital, Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Tong Yow Ng, MD, Principal investigator, Gleneagles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318625
- Sponsor's protocol ID
- PRHK02_TD8072
- Status last verified
- Aug 2023
- First submitted
- 25 Mar 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
- ClinicalTrials.gov ID
- NCT05318625
- Acronym / sponsor ID
- PRHK02_TD8072
- Conditions
- Ovarian Cancer, Cervical Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Precision Robotics (Hong Kong) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Gleneagles Hospital, Queen Mary Hospital, Hong Kong
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynaecological laparoscopic surgery | Experimental | Device: Gynaecological laparoscopic surgery (Sirius System)Eligible women aged 18 - 70 years, regardless of parity, who need laparoscopic gynaecological surgery and who provide informed consent prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are planned for Laparoscopic Gynecological Surgery (LGS)
- Patient is 18 years of age or older
- Signed written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Gynaecological laparoscopic surgery |
Primary outcome
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)
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
4 secondary outcomes
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
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
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
Postoperative complications related to the SIRIUS Endoscope System
Time frame: Through study completion, Up to 1 year from the first to the last patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- 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 studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tong Yow Ng, MD principal investigator
Gleneagles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gynaecological laparoscopic surgery (Sirius System) in people with Ovarian Cancer and Cervical Cancer, run by Precision Robotics (Hong Kong) Limited at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Assessment of SIRIUS Endoscope System. (time frame: Through study completion, Up to 1 year from the first to the last patients). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.