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

Terminated

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
NewBreez	NewBreez	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline Per Patient of Number and Severity of Aspiration Events	12 weeks	In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12

Secondary Outcome Measures

Name	Time	Method
Number of Reported Adverse Events	2 weeks	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
Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score	1 weeks	In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score: 0 = None 1. = Mild, some difficulty 2. = Moderate Difficulty but can continue 3. = Severe difficulty, cannot continue