NCT02419911

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Minimally Invasive Devices, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopic Surgery

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic surgery	gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
DEVICE	FloShield Defogging and Cleaning System	Sterile, single-use in vivo device to clean and defog the laparoscope camera lens
DEVICE	Clearify Defogging and Cleaning System	Single-use, ex vivo device to clean and defog the laparoscope camera lens

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-04-17
• Last updated: 2015-09-28

Locations

3 sites across 1 country: United States