CeraShield™ Endotracheal Tube Feasibility Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03716713

Enrollment

Registered

2018-10-23

Start date

2018-11-30

Completion date

2019-10-30

Last updated

2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Intratracheal

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.

Interventions

DEVICECeraShield Endotracheal Tube

Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Adverse Events	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

Measure	Time frame	Description
Positive QEA	10 days post intubation	Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours
Positive ETT colonization	10 days post intubation	Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours

Countries

Canada

Contacts

Primary ContactJane Wilson

janew@databean.com845-721-8210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026