NCT02419911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 28, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

April 1, 2015

Last Update Submit

September 25, 2015

Conditions

Laparoscopic Surgery

Keywords

gastrointestinalgynecologicurologicbariatriclaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • number of Laparoscope removals during surgery

    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

Study Arms (2)

FloShield

OTHER

FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery

Procedure: Laparoscopic surgeryDevice: FloShield Defogging and Cleaning System

Clearify

OTHER

Clearify Visualization System used during laparoscopic surgery

Procedure: Laparoscopic surgeryDevice: Clearify Defogging and Cleaning System

Interventions

Laparoscopic surgeryPROCEDURE

gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;

ClearifyFloShield
FloShield Defogging and Cleaning SystemDEVICE

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

Also known as: FloShield System
FloShield
Clearify Defogging and Cleaning SystemDEVICE

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

Clearify

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or Male;
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

South Miami Hospital

South Miami, Florida, 33143, United States

Location

Centennial Hills Medical Center

Las Vegas, Nevada, 89149, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45206, United States

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Wayne Poll, MD

    President and CEO

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 17, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 28, 2015

Record last verified: 2015-05

Locations

US(3)