Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy
Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy
The study will examine the safety and performance of a new surgical smoke clearance system
 designed for use during laparoscopic surgery.
The study will examine the safety and performance of a new surgical smoke clearance system
 which has been developed to maintain a visually clear operative field during laparoscopic
 surgery by using electrostatic precipitation to clear, from the surgical field, smoke and
 plume produced by energy based surgical instruments e.g. electrocautery, laser tissue
 ablation and ultrasonic scalpel tissue dissection.
Inclusion Criteria:

 1. Male or female, at least 18 years of age

 2. Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone
 disease

 3. Patient or authorised representative must be able to comprehend and sign the Informed
 Consent Form prior to enrolment in the study.

 Exclusion Criteria:

 1. <18 years of age

 2. Pregnant or lactating females

 3. Previous extensive abdominal surgery, which in the opinion of the Investigator
 presents a >5% risk of conversion to an open procedure being required

 4. Current participation in another device or drug study

 5. Unwilling or unable to provide informed consent