Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sirius in Gynaecological Laparoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05048407
Recruitment Status : Completed
First Posted : September 17, 2021
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
Gleneagles Hospital
Information provided by (Responsible Party):
Precision Robotics (Hong Kong) Limited

Brief 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. The aim of this IDEAL-D Stage 1 study was to demonstrate that the Sirius System could safely replace the conventional laparoscope in the surgical workflow for minimally invasive gynaecological laparoscopic surgery

Condition or disease Intervention/treatment Phase
Ovarian Cancer Cervical Cancer Gynecologic Cancer Device: Gynaecological laparoscopic surgery (Sirius System) Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Operative Time [ Time Frame: Duration of the procedure ]
    Duration of surgery measured in minutes from urinary catheter insertion to closure of vaginal/abdominal wound.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women-only
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible women aged 18 - 70 years, regardless of parity, who need laparoscopic gynaecological surgery and who provide informed consent prior to surgery

Exclusion Criteria:

  • Pregnancy
  • failure in providing informed consent

Information from the National Library of Medicine

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


Locations
Layout table for location information
Hong Kong
Gleneagles Hospital Hong Kong
Wong Chuk Hang, Hong Kong
Sponsors and Collaborators
Precision Robotics (Hong Kong) Limited
Gleneagles Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tong Yow Ng, MD Gleneagles Hospital
  Study Documents (Full-Text)

Documents provided by Precision Robotics (Hong Kong) Limited:
Study Protocol  [PDF] February 18, 2021
Informed Consent Form  [PDF] February 18, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Precision Robotics (Hong Kong) Limited
ClinicalTrials.gov Identifier: NCT05048407    
Other Study ID Numbers: PRHK HKU-GHK IRB 2021-01
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No