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| Name | Class |
|---|---|
| Gleneagles Hospital | OTHER |
| Queen Mary Hospital, Hong Kong | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women-only
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| Name | Affiliation | Role |
|---|---|---|
| Tong Yow Ng, MD | Gleneagles Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gleneagles Hospital Hong Kong | Wong Chuk Hang | Hong Kong |
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| Label | URL |
|---|---|
| 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 | View source |
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| Intraoperative adverse events related to the SIRIUS Endoscope System | Through study completion, Up to 1 year from the first to the last patients |
| Postoperative complications related to the SIRIUS Endoscope System | Through study completion, Up to 1 year from the first to the last patients |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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