Clinical trial NCT02437513: NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
Official title: NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aspiration
Laryngeal Cancer
Keywords: Dysphagia
Aspiration
Laryngeal cancer
Lead sponsor: ProTiP Medical
Sponsor class: INDUSTRY
First posted: 2015-05-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment of patients will primarily be from the department of Ear, Nose and Throat at the hospitals participating in the study. Secondary recruitment could also include associated clinics that treat patients with laryngeal dysfunction and aspiration, such as swallowing therapy clinics, speech language therapy clinics, and linguistics clinics.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline Per Patient of Number and Severity of Aspiration Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Reported Adverse Events
timeFrame: at device implantation
measure: Number of Reported Adverse Events
timeFrame: 2 weeks
measure: Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
timeFrame: 1 weeks
Other outcomes:
measure: Number of Participants With Reported Device Migration in the Larynx Post Implant
timeFrame: 1 weeks
measure: Change From Baseline of Quality of Life (QoL) Score
timeFrame: 12 weeks
measure: Reported Subjective Rating of Comfort of the Device in the Larynx
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: University of Luebeck
name: Ursula Schroeder, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: