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

NCT ID: NCT02419911

Last Updated: 2015-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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

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Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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FloShield

FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery

Group Type OTHER

Laparoscopic surgery

Intervention Type PROCEDURE

gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;

FloShield Defogging and Cleaning System

Intervention Type DEVICE

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

Clearify

Clearify Visualization System used during laparoscopic surgery

Group Type OTHER

Laparoscopic surgery

Intervention Type PROCEDURE

gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;

Clearify Defogging and Cleaning System

Intervention Type DEVICE

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

Interventions

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Laparoscopic surgery

gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;

Intervention Type PROCEDURE

FloShield Defogging and Cleaning System

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

Intervention Type DEVICE

Clearify Defogging and Cleaning System

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

Intervention Type DEVICE

Other Intervention Names

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FloShield System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minimally Invasive Devices, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wayne Poll, MD

Role: STUDY_DIRECTOR

President and CEO

Locations

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South Miami Hospital

South Miami, Florida, United States

Site Status

Centennial Hills Medical Center

Las Vegas, Nevada, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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FSA-0001

Identifier Type: -

Identifier Source: org_study_id

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