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

September 25, 2015 updated by: Minimally Invasive Devices, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • South Miami Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89149
        • Centennial Hills Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FloShield
FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery
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
Other Names:
  • FloShield System
Other: Clearify
Clearify Visualization System used during laparoscopic surgery
Procedure: Laparoscopic surgery
gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
Device: Clearify Defogging and Cleaning System
Single-use, ex vivo device to clean and defog the laparoscope camera lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of Laparoscope removals during surgery
Time Frame: 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.
0.5hr - 6hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minimally Invasive Devices, Inc.

Investigators

  • Study Director: Wayne Poll, MD, President and CEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FSA-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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