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Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy

NCT ID: NCT01534832

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Focus: Surgical Smoke During Laparoscopic Surgery

Keywords

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surgical smoke laparoscopic surgery impaired vision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Smoke clearance

Smoke clearance device active

Group Type EXPERIMENTAL

Innervision Surgical Smoke Removal System

Intervention Type DEVICE

Smoke removal by electrostatic precipitation

Interventions

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Innervision Surgical Smoke Removal System

Smoke removal by electrostatic precipitation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asalus Medical Instruments Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jared Torkington, MBBS MS FRCS

Role: PRINCIPAL_INVESTIGATOR

Cardiff and Vale UHB, Wales, UK

Locations

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University Hospital Llandough

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AMIL/2011/INV01

Identifier Type: -

Identifier Source: org_study_id