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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01534832
First Posted: February 17, 2012
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asalus Medical Instruments Limited
  Purpose
The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Asalus Medical Instruments Limited:

Primary Outcome Measures:
  • Maintenance of a clear visual field during surgery [ Time Frame: 3m ]

Enrollment: 30
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smoke clearance
Smoke clearance device active
Device: Innervision Surgical Smoke Removal System
Smoke removal by electrostatic precipitation

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534832


Locations
United Kingdom
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
  More Information

Responsible Party: Asalus Medical Instruments Limited
ClinicalTrials.gov Identifier: NCT01534832     History of Changes
Other Study ID Numbers: AMIL/2011/INV01
First Submitted: February 10, 2012
First Posted: February 17, 2012
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Asalus Medical Instruments Limited:
surgical smoke
laparoscopic surgery
impaired vision