TriangleNCT02437513 · REGISTRY CONDITION SEARCH
NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- TERMINATED
- Registry last update
- 2017-08-24
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Change From Baseline Per Patient of Number and Severity of Aspiration Events
Number of Reported Adverse Events
Number of Reported Adverse Events
Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
Number of Participants With Reported Device Migration in the Larynx Post Implant
Change From Baseline of Quality of Life (QoL) Score
Reported Subjective Rating of Comfort of the Device in the Larynx
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
- 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.
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Device: NewBreez
- label
- NewBreez
- interventions
- arm Group Labels
- NewBreez
- description
- Intralaryngeal prosthesis to protect the airways
- name
- NewBreez
- other Names
- Intralaryngeal Prosthesis
- type
- DEVICE
Study design
- observational Model
- CASE_ONLY
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 2
- type
- ACTUAL
Registered outcome plans (not posted results)
- other Outcomes
- description
- In patient change from baseline position of the device in the larynx of each patient assessed by endoscopy and/or other clinically appropriate methods (CT or video fluoroscopy) and recorded in migration direction and distance (cm)
- measure
- Number of Participants With Reported Device Migration in the Larynx Post Implant
- time Frame
- 1 weeks
- description
- In patient QoL assessed at baseline and at 12 weeks using German standard QoL clinical questionnaire specifically for patients with swallowing dysfunction
- measure
- Change From Baseline of Quality of Life (QoL) Score
- time Frame
- 12 weeks
- description
- In patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12
- measure
- Reported Subjective Rating of Comfort of the Device in the Larynx
- time Frame
- 12 weeks
- primary Outcomes
- description
- In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
- measure
- Change From Baseline Per Patient of Number and Severity of Aspiration Events
- time Frame
- 12 weeks
- secondary Outcomes
- description
- Analysis of the reported system or procedure related adverse events using standard AE reporting form
- measure
- Number of Reported Adverse Events
- time Frame
- at device implantation
- description
- 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
- measure
- Number of Reported Adverse Events
- time Frame
- 2 weeks
- description
- 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
- measure
- Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score
- time Frame
- 1 weeks
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- offset unit
- unicode_code_points
- query cond
- Laryngeal Cancer
- query disease state id
- ds-laryngeal-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
- source file sha256
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Preserved source evidence · Not medical advice