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

Laparoscopic Surgery Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02419911
Study type Interventional
Source Minimally Invasive Devices, Inc.
Contact
Status Completed
Phase Phase 4
Start date January 2015
Completion date September 2015
View Details
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