NL-OMON42228
Completed
N/A
An early clinical feasibility study of a new prosthesis: the NewBreez® Intralaryngeal device; a possible solution for severe aspiration in head and neck cancer patients - An intralaryngeal device for a dysfunctional larynx
Antoni van Leeuwenhoek Ziekenhuis0 sites5 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- aspiration
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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