Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Carcinoma Clinical Trial

Official title:

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00396617
• Other study ID #: 3736
• Status: Recruiting
• Phase: Phase 1
• First received: November 6, 2006
• Last updated: June 28, 2012
• Start date: December 2007
• Est. completion date: March 2014

Study information

• Verified date: June 2012
• Source: University Hospital, Strasbourg, France
• Contact: Christian DEBRY, MD
• Phone: 33.3.88.12.76.44
• Email: christian.debry[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Laryngeal Neoplasms
• Neoplasms
• Pharyngeal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	OseoAnvar, Réseau National des Technologies de Santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	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