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

Sponsor

Asalus Medical Instruments Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01534832

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Focus: Surgical Smoke During Laparoscopic Surgery	Device: Innervision Surgical Smoke Removal System	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Assessment of a New Surgical Smoke Clearing Technology, "Innervision", in Laparoscopic Cholecystectomy

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Smoke clearance Smoke clearance device active	Device: Innervision Surgical Smoke Removal System Smoke removal by electrostatic precipitation

Arm

Intervention/Treatment

Experimental: Smoke clearance

Smoke clearance device active

Device: Innervision Surgical Smoke Removal System

Smoke removal by electrostatic precipitation

Outcome Measures

Primary Outcome Measures

Maintenance of a clear visual field during surgery [3m]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female, at least 18 years of age
Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease
Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.

Exclusion Criteria:

<18 years of age
Pregnant or lactating females
Previous extensive abdominal surgery, which in the opinion of the Investigator presents a >5% risk of conversion to an open procedure being required
Current participation in another device or drug study
Unwilling or unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Llandough	Cardiff	Wales	United Kingdom	CF64 2XX

Sponsors and Collaborators

Asalus Medical Instruments Limited

Investigators

Principal Investigator: Jared Torkington, MBBS MS FRCS, Cardiff and Vale UHB, Wales, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asalus Medical Instruments Limited

ClinicalTrials.gov Identifier:

NCT01534832

Other Study ID Numbers:

AMIL/2011/INV01

First Posted:

Feb 17, 2012

Last Update Posted:

Aug 15, 2012

Last Verified:

Aug 1, 2012

Keywords provided by Asalus Medical Instruments Limited

surgical smoke

laparoscopic surgery

impaired vision

Study Results

No Results Posted as of Aug 15, 2012