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A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization

NCT02756351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-02-01

Study results available
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Summary

The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.

Conditions

  • Nosocomial Infections
  • Pneumonia, Ventilator-Associated

Interventions

DEVICE

CytaCoat Nasal Prong

DEVICE

Inspiration Healthcare Inspire nCPAP Nasal Prong

Sponsors & Collaborators

  • CytaCoat AB

    lead INDUSTRY

Principal Investigators

  • Baldvin Jonsson · Neonatal, Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • Sweden

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 NCT02756351 on ClinicalTrials.gov