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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asalus Medical Instruments Limited
ClinicalTrials.gov Identifier:
NCT01534832
First received: February 10, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (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:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Asalus Medical Instruments Limited:

Primary Outcome Measures:
  • Maintenance of a clear visual field during surgery [ Time Frame: 3m ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Asalus Medical Instruments Limited
ClinicalTrials.gov Identifier: NCT01534832     History of Changes
Other Study ID Numbers: AMIL/2011/INV01
Study First Received: February 10, 2012
Last Updated: August 14, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013