CompletedPhase 1/2

Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy

United Kingdom30 participantsStarted 2012-04

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. \<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

Maintenance of a clear visual field during surgery

Timeframe: 3m

NCT IDNCT01534832

SponsorAsalus Medical Instruments Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08