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

Completed

Conditions: aspiration
Dysfunctional larynx
swallowing impairment
10027656

Registration Number: NL-OMON42228

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety endpoints:<br /><br>o Adverse events, including adverse device effects: dislocation, damage to the<br /><br>larynx<br /><br>o Implant tolerance<br /><br>o Reversibility if/when removed </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Performance and efficacy endpoints:<br /><br>o Technical success of the implantation procedure<br /><br>o Implant placement and integrity, as assessed by nasopharyngoscopy<br /><br>o Eating (diet, oral intake and/or feeding tube dependency)<br /><br>o Breathing (tracheotomy dependency)<br /><br>o Aspiration, as assessed by direct visualization and videofluoroscopy at one<br /><br>week and 6 months after placement<br /><br><br /><br>Patient satisfaction:<br /><br>o Quality of Life, as assessed by the SWAL-QOL questionnaire<br /><br>o Specific questions on tolerance and problems with the device</p><br>