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Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Collaborators:
OseoAnvar
Réseau National des Technologies de Santé
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00396617
First received: November 6, 2006
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pharyngeal Neoplasms
Laryngeal Neoplasms
Carcinoma
 Device: prothesis voice
Procedure: total laryngectomy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Clinical measures concerning peri and intra prosthetic leakage [ Time Frame: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phonology's measures [ Time Frame: months 1, 3,12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: December 2007
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396617

Contacts
Contact: Christian DEBRY, MD 33.3.88.12.76.44 christian.debry@chru-strasbourg.fr

Locations
France
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67082
Contact: Christian DEBRY, MD     33.3.88.12.76.44     christian.debry@chru-strasbourg.fr    
Sub-Investigator: Patrick HEMAR, MD            
Sub-Investigator: Philippe SCHULTZ, MD            
Principal Investigator: Christian DEBRY, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
OseoAnvar
Réseau National des Technologies de Santé
Investigators
Principal Investigator: Christian DEBRY, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00396617     History of Changes
Other Study ID Numbers: 3736
Study First Received: November 6, 2006
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Laryngeal or pharyngo-laryngeal's carcinoma,
voice prosthesis tracheooesophageal shunt,
titanium beads,
cellular colonization
Laryngeal or pharyngo-laryngeal's carcinoma

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Laryngeal Neoplasms
Pharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
 Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013