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

Phase 4

Completed

• Conditions: Laparoscopic Surgery
• Interventions: Procedure: Laparoscopic surgery; Device: Clearify Defogging and Cleaning System; Device: FloShield Defogging and Cleaning System

• Registration Number: NCT02419911
• Lead Sponsor: Minimally Invasive Devices, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Status Verified: 2015-05
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clearify	Clearify Defogging and Cleaning System	Clearify Visualization System used during laparoscopic surgery
FloShield	FloShield Defogging and Cleaning System	FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery
Clearify	Laparoscopic surgery	Clearify Visualization System used during laparoscopic surgery
FloShield	Laparoscopic surgery	FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery

Primary Outcome Measures

Name	Time	Method
number of Laparoscope removals during surgery	0.5hr - 6hr	The performance evaluations of the FloShield Air System will be based the difference between the cohorts on the number of scope removals per surgery.

Trial Locations

Locations (3)

South Miami Hospital; 🇺🇸 South Miami, Florida, United States

Centennial Hills Medical Center; 🇺🇸 Las Vegas, Nevada, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States