Comparison FloShield Air System Versus Clearify Visualization System (D-HELP)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Randomized Comparison of the Use of FloShield Air System Versus Clearify Visualization System (D-HELP) During Laparoscopic Surgery to Evaluate the Operative Interruption for Lens Cleaning

Conditions
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Laparoscopic Surgery

Intervention / Treatment
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* Procedure: Laparoscopic surgery
* Device: FloShield Defogging and Cleaning System
* Device: Clearify Defogging and Cleaning System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or Male; 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: Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator); Use of Surgiquest AirSeal®; Use of humidified insufflation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FloShield<br>FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery | Procedure: Laparoscopic surgery<br>* gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;<br>Device: FloShield Defogging and Cleaning System<br>* Sterile, single-use in vivo device to clean and defog the laparoscope camera lens<br>* Other names: FloShield System;|
| Other: Clearify<br>Clearify Visualization System used during laparoscopic surgery | Procedure: Laparoscopic surgery<br>* gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;<br>Device: Clearify Defogging and Cleaning System<br>* Single-use, ex vivo device to clean and defog the laparoscope camera lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0.5hr - 6hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal, gynecologic, urologic, bariatric, laparoscopic surgery