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

NCT02419911 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-09-28

No results posted yet for this study

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.

Conditions

  • Laparoscopic Surgery

Interventions

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

DEVICE

Clearify Defogging and Cleaning System

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

Sponsors & Collaborators

  • Minimally Invasive Devices, Inc.

    lead INDUSTRY

Principal Investigators

  • Wayne Poll, MD · President and CEO

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02419911 on ClinicalTrials.gov