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CeraShield™ Endotracheal Tube Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716713
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
N8 Medical, LLC

Brief Summary:
Single-arm, feasibility study to evaluate the Ceragenin Coated Endotracheal Tube (the CeraShield ETT) in adults who require intubation and are expected to be mechanically ventilated for ≥ 24 hours.

Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Device: CeraShield Endotracheal Tube Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: CeraShield™ Endotracheal Tube Feasibility Study
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
Experimental: CeraShield Endotracheal Tube
Subjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT.
Device: CeraShield Endotracheal Tube
Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Up to 30 days post enrollment or hospital discharge, whichever comes first ]
    The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study


Secondary Outcome Measures :
  1. Positive QEA [ Time Frame: 10 days post intubation ]
    Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours

  2. Positive ETT colonization [ Time Frame: 10 days post intubation ]
    Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18 years or older;
  • Patients requiring a 7.0mm, 7.5mm, 8.0mm or 8.5mm endotracheal tube;
  • Expected to be mechanically ventilated for ≥24 hours.

Exclusion Criteria:

  • Currently participating in another clinical trial which conflicts with this trial's design.
  • Patients with a pre-existing respiratory infection, i.e., pneumonia.
  • Patients with pulmonary contusions.
  • Patients with cystic fibrosis.
  • Patients demonstrating symptoms of bronchiectasis.
  • Patients demonstrating symptoms of severe or massive hemoptysis. Severe or massive hemoptysis defined as greater than 500 ml of blood per day, or greater than 200 ml in six hours.
  • Patients who have been intubated within the last 30 days requiring reintubation.
  • Women of child-bearing potential who have not undergone a pregnancy test will be excluded from the study.
  • Patient is pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716713


Contacts
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Contact: Jane Wilson 845-721-8210 janew@databean.com

Locations
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Canada, Ontario
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Miranda Hunt    613 549 6666 ext 3190    miranda.hunt@kingstonhsc.ca   
Contact: Tracy Boyd    613 549 6666 ext 2608    tracy.boyd@kingstonhsc.ca   
Principal Investigator: John Muscedere, MD         
Sponsors and Collaborators
N8 Medical, LLC

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Responsible Party: N8 Medical, LLC
ClinicalTrials.gov Identifier: NCT03716713    
Other Study ID Numbers: N8-2018-02
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No