NCT00396617

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pharyngeal Neoplasms
• Laryngeal Neoplasms
• Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2013-09-01
• Completion: 2014-03-01
• First posted: 2006-11-07
• Last updated: 2012-07-02

Locations

1 site across 1 country: France