Dysphagia, Laryngeal Neoplasms, Swallowing Disorders
Conditions
Keywords
Larynx, tracheotomy, titanium beads
Brief summary
Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. The secondary objective is to study the concept of a special valves system for the development of an artificial larynx
Interventions
DEVICEImplantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing
An artificial Larynx composed of a tracheobronxane ® Dumon ST prosthesis and a valves system will be implant under general anesthesia by endoscopy. The 3 first patients will be patients with tracheotomy, in order to allow breathing through this tracheotomy in case of valves dysfunction.
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age more than 18 * Swallowing troubles
Exclusion criteria
* Pregnant women * Contraindications to general anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory evaluation | Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36 |
Secondary
| Measure | Time frame |
|---|---|
| Nasofibroscopy | Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36 |
Countries
France
Outcome results
None listed