Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy

Asalus Medical Instruments Limited30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Focus: Surgical Smoke During Laparoscopic Surgery

Interventions

Innervision Surgical Smoke Removal SystemDEVICE

Smoke removal by electrostatic precipitation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Llandough

Cardiff, Wales, United Kingdom

Outcomes

Primary Outcomes

Maintenance of a clear visual field during surgery

Time frame: 3m

Data from ClinicalTrials.gov

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