Comparison FloShield Air System Versus Clearify Visualization System (D-HELP)
NCT ID: NCT02419911
Last Updated: 2015-09-28
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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COMPLETED
PHASE4
62 participants
INTERVENTIONAL
2015-01-31
2015-09-30
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
NONE
Study Groups
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FloShield
FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery
Laparoscopic surgery
gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
FloShield Defogging and Cleaning System
Sterile, single-use in vivo device to clean and defog the laparoscope camera lens
Clearify
Clearify Visualization System used during laparoscopic surgery
Laparoscopic surgery
gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
Clearify Defogging and Cleaning System
Single-use, ex vivo device to clean and defog the laparoscope camera lens
Interventions
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Laparoscopic surgery
gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
FloShield Defogging and Cleaning System
Sterile, single-use in vivo device to clean and defog the laparoscope camera lens
Clearify Defogging and Cleaning System
Single-use, ex vivo device to clean and defog the laparoscope camera lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older;
* Patient scheduled for gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery under the care of the study investigator;
* Suitable candidate for surgery
Exclusion Criteria
* Use of Surgiquest AirSeal®;
* Use of humidified insufflation
18 Years
ALL
No
Sponsors
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Minimally Invasive Devices, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wayne Poll, MD
Role: STUDY_DIRECTOR
President and CEO
Locations
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South Miami Hospital
South Miami, Florida, United States
Centennial Hills Medical Center
Las Vegas, Nevada, United States
University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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FSA-0001
Identifier Type: -
Identifier Source: org_study_id
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