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

Study Overview
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Brief Summary
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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.

Detailed Description
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Aspiration is associated with respiratory tract infections, reduced quality of life and increased mortality in patients. For chronic or unresolved aspiration, patients are often given a tracheostomy for safer breathing and greater protection of the airways from aspirated material. However tracheostomies are associated with risks and complications and do not give a 100% guarantee of aspiration protection to the patient. They also impact the quality of life in a negative way for many patients. The current study will evaluate the performance of a new intralaryngeal device for airway protection in a small group of patients who have chronic aspiration. The study will look at the overall performance of this device in preventing aspiration in this specific group of patients as well as determine any unforeseen risks of using this device in the identified group of patients. The outcomes will form the basis of future studies with larger groups of patients.

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

Conditions
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Aspiration, Laryngeal Cancer

Intervention / Treatment
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* Device: NewBreez


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of head and neck cancer Chronic aspiration Currently has a tracheostomy Patient is able to independently maintain their tracheostomy and cannula apparatus Patient meets the CE Mark indications and are not contraindicated for a NewBreez procedure. Anatomically compatible with the available sizes of NewBreez® 18 years of age or older Sufficient cognitive function to comply with the study and follow-up requirements Patient gives voluntary signed informed consent Exclusion Criteria: Recurrent or present cancer in the previous 12 months Absent cough reflex Severely disrupted swallowing function e.g. severe neurological deficit, absent swallowing reflex, severe fixation of the larynx due to scarring with absent elevation of the larynx Upper esophageal sphincter not functional e.g. remains closed Cor Pulmonale / Pulmonary Heart Disease, or current lung infection Mouth opening less than 3.5cm Neck extension severely restricted hindering implantation of the device Contraindication to general anesthesia Severe hyperostosis (spondylophytes) of the cervical vertebrae causing dysphagia Severe (radiogenic) edema or damage of the mucosa of the upper aerodigestive tract

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NewBreez<br>The study group is composed only of patients who have already opted to receive the NewBreez device as part of their routine care from their physician. Patients who have the device implanted, and consent to be part of the 12 week observational study, will be enrolled and have standard clinical parameters measured over the 12 week period as well as complete quality of life assessments in the form of patient questionnaires. | Device: NewBreez<br>* Intralaryngeal prosthesis to protect the airways<br>* Other names: Intralaryngeal Prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Per Patient of Number and Severity of Aspiration Events | In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Reported Adverse Events | Analysis of the reported system or procedure related adverse events using standard AE reporting form | at device implantation | 
| Number of Reported Adverse Events | Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period | 2 weeks | 
| Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score | In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score: 0 = None = Mild, some difficulty = Moderate Difficulty but can continue = Severe difficulty, cannot continue | 1 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Aspiration, Laryngeal cancer