CClinicalTrials.gg
Sign In
Status unknownNCT03716713Updated Aug 20, 2019

CeraShield™ Endotracheal Tube Feasibility Study

An interventional study of CeraShield Endotracheal Tube in Intubation, Intratracheal, sponsored by N8 Medical, LLC. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by N8 Medical, LLC · Not applicable, Interventional, and Device feasibility

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intubation, Intratracheal
03

In context

Lead sponsor

This is the only study on the registry with N8 Medical, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceCeraShield Endotracheal Tube

    Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events

    The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study

    Time frame: Up to 30 days post enrollment or hospital discharge, whichever comes first

Secondary outcomes

  1. Positive QEA

    Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours

    Time frame: 10 days post intubation

  2. Positive ETT colonization

    Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours

    Time frame: 10 days post intubation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03716713
Lead sponsor
N8 Medical, LLC
Responsible party
Sponsor
First posted
Oct 23, 2018
Start date
Nov 30, 2018
Primary completion
Oct 30, 2019 (estimated)
Completion
Oct 30, 2019 (estimated)
Last update
Aug 20, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion