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NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration

NCT02437513 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2017-08-24

Study results available
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Summary

Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences of aspiration and respiratory tract complications such as aspiration pneumonia. Current standard of care treatment to reduce the consequences of aspiration is often a tracheostomy which has its own risks and complications. The proposed study aims to describe the performance of a new CE marked medical implant, the NewBreez, in protecting the patient's airways from aspiration.

Conditions

  • Aspiration
  • Laryngeal Cancer

Interventions

DEVICE

NewBreez

Intralaryngeal prosthesis to protect the airways

Sponsors & Collaborators

  • ProTiP Medical

    lead INDUSTRY

Principal Investigators

  • Ursula Schroeder, Dr. med. · University of Luebeck

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-07-31
Completion
2016-11-30

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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 NCT02437513 on ClinicalTrials.gov