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

August 14, 2012 updated by: Asalus Medical Instruments Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF64 2XX
        • University Hospital Llandough

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maintenance of a clear visual field during surgery
Time Frame: 3m
3m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asalus Medical Instruments Limited

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMIL/2011/INV01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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