aspiration Dysfunctional larynx swallowing impairment
Conditions
Interventions
Placement of the NewBreez® Intralaryngeal prosthesis.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients who have been treated successfully for HNC and are free of disease minimally one year after treatment; and - Patients with difficulties in feeding and/or breathing due to a dysfunctional larynx, necessitating prolonged (> 6 months) use of a (nasogastric or percutaneous) feeding tube and a tracheotomy, which are unlikely to be removed; and - Patients who are motivated to undergo the operation; and - Patients are willing to provide written informed consent prior to participation.
Exclusion criteria
Exclusion criteria: - Patients under the age of 18 years; or - Patients with clotting disorders; or - Patients with Chronic Obstructive Pulmonary Disease (COPD); or - Patients with recurrent or residual HNC disease; or - Patients with upper esophageal obstruction or stenosis on videofluoroscopy; or - Patients who are unfit to undergo general anaesthesia, as judged by the anaesthetist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: o Adverse events, including adverse device effects: dislocation, damage to the larynx o Implant tolerance o Reversibility if/when removed | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance and efficacy endpoints: o Technical success of the implantation procedure o Implant placement and integrity, as assessed by nasopharyngoscopy o Eating (diet, oral intake and/or feeding tube dependency) o Breathing (tracheotomy dependency) o Aspiration, as assessed by direct visualization and videofluoroscopy at one week and 6 months after placement Patient satisfaction: o Quality of Life, as assessed by the SWAL-QOL questionnaire o Specific questions on tolerance and problems with the device | — |
Countries
Netherlands
Outcome results
None listed