Focus: Surgical Smoke During Laparoscopic Surgery
Conditions
Keywords
surgical smoke, laparoscopic surgery, impaired vision
Brief summary
The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.
Detailed description
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.
Interventions
DEVICEInnervision Surgical Smoke Removal System
Smoke removal by electrostatic precipitation
Sponsors
Asalus Medical Instruments Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of a clear visual field during surgery | 3m |
Countries
United Kingdom
Outcome results
None listed