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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02419911

Enrollment

Registered

2015-04-17

Start date

2015-01-31

Completion date

2015-09-30

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Surgery

Keywords

gastrointestinal, gynecologic, urologic, bariatric, laparoscopic surgery

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.

Interventions

PROCEDURELaparoscopic surgery

gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;

DEVICEFloShield Defogging and Cleaning System

Sterile, single-use in vivo device to clean and defog the laparoscope camera lens

DEVICEClearify Defogging and Cleaning System

Single-use, ex vivo device to clean and defog the laparoscope camera lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026