Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy (Innervision)

Asalus Medical Instruments

Status and phase: Completed; Phase 2; Phase 1

Conditions: Focus: Surgical Smoke During Laparoscopic Surgery

Treatments: Device: Innervision Surgical Smoke Removal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534832

AMIL/2011/INV01

Details and patient eligibility

About

The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 1 patient group

Smoke clearance

Experimental group

Description:

Smoke clearance device active

Treatment:

Device: Innervision Surgical Smoke Removal System