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OpenTrials
Completed

NCT Number: NCT01534832

Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Llandough

Cardiff, Wales, CF64 2XX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Innervision Surgical Smoke Removal System

Device

Smoke removal by electrostatic precipitation

Primary outcomes

  1. Maintenance of a clear visual field during surgery

    Time frame: 3m

Sponsors and collaborators

Lead sponsor

Asalus Medical Instruments Limited

Industry

Registry information

Official study title

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

Acronym: Innervision

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2012
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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