This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery. The study will be randomized across two groups, one group will evaluate laparoscopic lens cleaning with D-HELP during laparoscopic surgery and the second group will evaluate laparoscopic lens cleaning using the FloShield Air System during laparoscopic surgery. Each surgery will be captured on video. Study parameters will be evaluated through review of each video by an independent evaluator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
62
gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
Sterile, single-use in vivo device to clean and defog the laparoscope camera lens
Single-use, ex vivo device to clean and defog the laparoscope camera lens
South Miami Hospital
South Miami, Florida, United States
Centennial Hills Medical Center
Las Vegas, Nevada, United States
University of Cincinnati
Cincinnati, Ohio, United States
number of Laparoscope removals during surgery
The performance evaluations of the FloShield Air System will be based the difference between the cohorts on the number of scope removals per surgery.
Time frame: 0.5hr - 6hr
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