Clinical trial · Observational
NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment rates too low to continue with the study
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aspiration | — | UNRESOLVED | — |
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NewBreez | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NewBreez
- 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.
- interventionNames
- Device: NewBreez
Primary outcomes (1)
- measure
- Change From Baseline Per Patient of Number and Severity of Aspiration Events
- timeFrame
- 12 weeks
- description
- In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12
Secondary outcomes (3)
- measure
- Number of Reported Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available