Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification Date
Recruiting	Pharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma	University Hospital, Strasbourg, France Other collaborator(s): OseoAnvar; Réseau National des Technologies de Santé	November 6, 2006	June 28, 2012	June 2012

Study Type	Study Design	Phase	Enrollment	Start Date	End Date
Interventional	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment	Phase 1	14	December 2007	-

Facility	Address	Contact	Phone	Email	Status
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg 67082 France	Christian DEBRY, MD	-	christian.debry@chru-strasbourg.fr	Recruiting

Type	Intervention	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.

Type	Measure	Time Frame	Safety Issue
Primary	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	No
Secondary	Phonology's measures	months 1, 3,12	No

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Gender	Minimum Age	Maximum Age	Healthy Volunteers
Both	-	N/A	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