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Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS

NCT04162106 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-22

No results posted yet for this study

Summary

This post-market clinical study is designed to evaluate the effectiveness of the Ultravision™ System when compared to the Airseal® iFS within an approved indication for use, namely laparoscopic cholosystectomy.

Conditions

  • Laparoscopic Cholecystectomy

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Alesi Surgical Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2020-01-31
Completion
2020-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04162106 on ClinicalTrials.gov