Aqueduct Irrigation System Clinical Protocol: Medical Device Investigational Plan

A. Synopsis

1. This protocol comes to direct the experiment to be performed on the Aqueduct Automatic Continuous Irrigation system.
2. The Aquaduct System is aimed at reducing risks to the patient by decreasing the irrigation fluid pressure he may be exposed to, reducing the procedure time and therefore the anesthesia time, reducing the manual handling of the sterile bags and the risk of contamination and more.
3. In general since there is no new procedure suggested and the equipment does not actually come into contact with the human body in any direct way, there is no need to have a clinical study for the regulation purpose. The reason for performing this experiment is to demonstrate the new system and to find out the best way to operate it in order to improve the process and reduce risks.
4. This information will serve the development of most suitable automation solution for achieving the long desired continuous irrigation.
5. The experiment will be performed in the OR in MIS procedures, and will replace the standard gravitational manual method of performing the irrigation. The surgeons and the medical staff of the OR will be directed with the set up and operation of the system prior to using it. The experiment will be accompanied at all times with a knowledgeable representative of the research originator.
6. A maximum of 30 procedures will be analyzed during a period of approximately one month. The surgeons and the medical staff will report their impression of using the system during the procedures and will recommend the best settings achieved.

This information will be used to improve the system performance and design.