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 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- 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.

•- 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.

发起方

Antoni van Leeuwenhoek Ziekenhuis