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

Minimally Invasive Devices, Inc.

Status and phase

Completed

Phase 4

Conditions

Laparoscopic Surgery

Treatments

Procedure: Laparoscopic surgery

Device: FloShield Defogging and Cleaning System

Device: Clearify Defogging and Cleaning System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02419911

FSA-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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