Clinical trial: NCT05048407
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risk And Complication Of The Procedure May Include, But Are Not Limited To The Following

- There is no anticipated additional risk for your laparoscopic surgery.  
- In the unlikely event of an equipment failure of the Sirius Robotic Flexible Endoscopic System, a conventional endoscope is always on standby to replace it without delay.  
I acknowledge that the above information concerning my operation/procedure have been explained to me and discussed with me by the medical staff and I fully understand them. I have been given the opportunity *to ask* questions pertinent to my condition and management and satisfactory answers have been provided by medical staff.  
I agree/disagree to participate in this trial.
Clinical trial: NCT05048407
Section: Purpose of Research
Subsections: Aim Of The Study

- 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 of this clinical trial is to assess if the Sirius Robotic Flexible Endoscopic System can replace the conventional endoscope in gynaecological laparoscopic procedures.  
- The only difference in the laparoscopic procedure is the replacement of the conventional endoscope by the Sirius Robotic Flexible Endoscopic System. All other instruments and procedures remain the same.
Clinical trial: NCT05048407
Section: Voluntary Participation
Subsections: Participation In The Trial

- As you are about to undergo a laparoscopic gynaecological procedure, you have been invited to participate in the trial.  
- Photographic and/or video images may be taken during the operation for education/ research/
documentation purpose. Your name and ID number will not be recorded and so your identity will not be disclosed. Please inform the staff if you have any objection.  
- Participation in the trial is voluntary, and your laparoscopic surgery will be done in the usual manner with a conventional endoscope should you choose not to participate in the trial.  
- The Sirius Robotic Flexible Endoscopic System will be used during the laparoscopic procedure, and the  
  
conventional endoscope will be on standby to replace it if necessary, for example in the unlikely event of a failure of the Sirius Robotic Flexible Endoscopic System to work. Your safety is always our priority.