Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS
NCT ID: NCT04162106
Last Updated: 2019-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-11-30
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ultravision™ System
Smoke management during laparoscopic cholecystectomy performed with the Ultravision™ System
Smoke management during laparoscopic cholecystectomy using the Ultravision™ System
The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.
Airseal® iFS
Smoke management during laparoscopic cholecsystectomy performed with the Airseal® iFS
Smoke management during laparoscopic cholecystectomy using the Airseal® iFS
The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.
Interventions
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Smoke management during laparoscopic cholecystectomy using the Ultravision™ System
The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.
Smoke management during laparoscopic cholecystectomy using the Airseal® iFS
The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.
Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure
* Agrees to attend all follow-up assessments
* Is indicated for elective laparoscopic cholecystectomy
Exclusion Criteria
* Patient anatomy i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively
* Body Mass Index \> 50
* Be pregnant (if female)
* Has a condition of unrelated chronic pain requiring medication
18 Years
ALL
No
Sponsors
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Alesi Surgical Ltd.
INDUSTRY
Responsible Party
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Locations
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Duke Regional Hospital
Durham, North Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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Pro00103233
Identifier Type: -
Identifier Source: org_study_id
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