Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
Conditions
Pharyngeal Neoplasms - Laryngeal Neoplasms - Carcinoma
Conditions: official terms
Laryngeal Neoplasms - 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
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: prothesis voice Type: Device
Name: total laryngectomy Type: Procedure
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Status: Recruiting
Contact: Christian DEBRY, MD - 33.3.88.12.76.44 - christian.debry@chru-strasbourg.fr
Start Date
December 2007
Completion Date
March 2014
Sponsors
University Hospital, Strasbourg, France
Source
University Hospital, Strasbourg, France
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page