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NCT Number: NCT02419911

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

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.

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Key information

Conditions

Laparoscopic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Miami Hospital, South Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic surgery

Procedure

gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;

FloShield Defogging and Cleaning System

Device

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

Other names: FloShield System

Clearify Defogging and Cleaning System

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Minimally Invasive Devices, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2015
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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