Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Study Overview
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Brief Summary
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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

Official Title
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Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Conditions
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Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma

Intervention / Treatment
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* Device: prothesis voice
* Procedure: total laryngectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: prothesis 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.|
|Procedure: total 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phonology's measures |  | months 1, 3,12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal or pharyngo-laryngeal's carcinoma,, voice prosthesis tracheooesophageal shunt,, titanium beads,, cellular colonization, Laryngeal or pharyngo-laryngeal's carcinoma