Carcinoma, Laryngeal Neoplasms, Pharyngeal Neoplasms
Conditions
Keywords
Laryngeal or pharyngo-laryngeal's carcinoma,, voice prosthesis tracheooesophageal shunt,, titanium beads,, cellular colonization, Laryngeal or pharyngo-laryngeal's carcinoma
Brief summary
The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions
Interventions
DEVICEprothesis voice
The device may be used for patient using another type of voice prosthesis, of for patient undergoing total laryngectomy. This device is definitively placed in two parts:The first one is introduced in the puncture (TEP) through the esophagus (retrograde way). The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
PROCEDUREtotal laryngectomy
The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.
Sponsors
OseoAnvar
Réseau National des Technologies de Santé
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 * total laryngectomy or pharyngo-larynctomy
Exclusion criteria
* pregnant women-age less than 18 * major pulmonary bronchitis * major neurological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical measures concerning peri and intra prosthetic leakage | days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36 |
Secondary
| Measure | Time frame |
|---|---|
| Phonology's measures | months 1, 3,12 |
Countries
France
Contacts
Primary ContactChristian DEBRY, MD
Outcome results
None listed