Sirius in Gynaecological Laparoscopic Surgery
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|ClinicalTrials.gov Identifier: NCT05048407|
Recruitment Status : Completed
First Posted : September 17, 2021
Last Update Posted : September 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Cervical Cancer Gynecologic Cancer||Device: Gynaecological laparoscopic surgery (Sirius System)||Not Applicable|
Laparoscopic procedures for benign gynaecology are well established. For gynaecological oncology, laparoscopic total hysterectomy bilateral salpingo-oophorectomy is the gold standard for the surgical management of early stage carcinoma of the corpus. Compared to laparotomy, laparoscopy is associated with reduced morbidity and quicker recovery with no compromise to overall survival. With advancement in laparoscopic technology, minimal access surgery has progressed to single incision laparoscopy(SILS) and natural orifice surgery(vNOTEs) thus further reducing morbidity and enhancing recovery.
Precision Robotics' Sirius System is a fully integrated compact 3D laparoscopic system with a flexible tip that can change its viewing direction. The articulated tip has three degrees of freedom enabling C and S-shaped bending providing a wider field of view compared to conventional laparoscopes. This wider field of view is of particular advantage for SILS and vNOTEs, and presently available commercial systems do not have the same field of view or degrees of freedom.
From September 2019 to July 2020, three animal studies were performed by Precision Robotics in collaboration with National Taiwan University Hospital and Shanghai Ruijin Hospital. Using the Sirius System, expert surgeons successfully conducted the following procedures:
- Laparoscopic Surgery - Performed a cholecystectomy where the gallbladder was removed from an animal model laparoscopically.
- Trans-anal Surgery - A small tissue sample was removed using an electronic knife to test the system's performance in a SILS operation with a porcine model.
- Orthopaedics Surgery - Conducted a MIS-TLIF (minimally invasive surgery - Transforaminal lumbar interbody fusion) operation on an animal cadaver.
Surgeons were able to complete their full surgical workflow using the system, and any feedback was incorporated in refining the system's design.
In addition to animal studies, the system's safety was demonstrated through extensive testing by qualified testing centres in compliance with electromagnetic compatibility (EMC) and electrical safety standards.
- Tested in accordance to IEC 60601-1-2: 2014 / EN 60601-1-2:2015, FCC 47CFR Part 15: 2018 ANSIC63.4:2014, IEC 60601-1:2005+AMD1:2012 and IEC 60601-2-18:2009,
- Biocompatibility test for all material in contact with patient body according to ISO 10993.
To assess the safety, reliability and efficacy of an articulated laparoscopic camera system - Precision Robotics' Sirius Robotic Flexible Endoscopic System in gynaecological laparoscopic surgery particularly for Single Incision Laparoscopic Surgery(SILS) and Vaginal Natural Orifice Transluminal Endoscopy(vNOTEs). The aim in this pilot study is to show that the Sirius System can safely replace the conventional endoscope in the surgical workflow for gynaecological laparoscopic surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of the Feasibility of an Articulated Laparoscopic Camera System - Precision Robotics' Sirius Robotic Flexible Endoscopic System in Gynaecological Laparoscopic Surgery|
|Actual Study Start Date :||May 17, 2021|
|Actual Primary Completion Date :||July 27, 2021|
|Actual Study Completion Date :||August 31, 2021|
Experimental: 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
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.
- The efficacy of the SIRIUS system in replacing conventional laparoscopes [ Time Frame: Duration of the procedure ]the proportion of women who successfully completed the intended procedure using the Sirius system without conversion to another camera system
- Operative Time [ Time Frame: Duration of the procedure ]Duration of surgery measured in minutes from urinary catheter insertion to closure of vaginal/abdominal wound.
- Intraoperative or Postoperative complications [ Time Frame: the first 6 weeks of surgery. ]Intraoperative or Postoperative complications according to Clavien-Dindo classification during the first 6 weeks of surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048407
|Gleneagles Hospital Hong Kong|
|Wong Chuk Hang, Hong Kong|
|Principal Investigator:||Tong Yow Ng, MD||Gleneagles Hospital|