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Smoke Management System

Airseal® iFS for Laparoscopic Cholecystectomy

N/A
Waitlist Available
Research Sponsored by Alesi Surgical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is 18 years or older
Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from the exposure and identification of the cystic duct and artery is complete to the last use of diathermy
Awards & highlights

Study Summary

This trial will compare the Ultravision™ System to the Airseal® iFS in people undergoing laparoscopic cholecystectomy (gallbladder removal).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from veress needle insertion to just prior to gall bladder removal
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from veress needle insertion to just prior to gall bladder removal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Carbon Dioxide Utilization
Quality of Visualization
Secondary outcome measures
Case Complexity
Diathermy Power Setting
End tidal CO2 Volume
+7 more

Trial Design

2Treatment groups
Active Control
Group I: Airseal® iFSActive Control1 Intervention
Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS
Group II: Ultravision™ SystemActive Control1 Intervention
Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System

Find a Location

Who is running the clinical trial?

Alesi Surgical Ltd.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Mar 2025