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Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

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ClinicalTrials.gov Identifier: NCT00396617
Recruitment Status : Unknown
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : November 7, 2006
Last Update Posted : July 2, 2012
Sponsor:
Collaborators:
OseoAnvar
Réseau National des Technologies de Santé
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

November 6, 2006
November 7, 2006
July 2, 2012
December 2007
September 2013   (Final data collection date for primary outcome measure)
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 ]
Clinical measures concerning peri and intra prosthetic leakage- days 8,15,21,30-months : 2,3,4,6,15,18,21,24,30
Complete list of historical versions of study NCT00396617 on ClinicalTrials.gov Archive Site
Phonology's measures [ Time Frame: months 1, 3,12 ]
Phonology's measures - months 1, 3,12
Not Provided
Not Provided
 
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Carcinoma
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
14
Same as current
March 2014
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00396617
3736
No
Not Provided
Not Provided
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
  • OseoAnvar
  • Réseau National des Technologies de Santé
Principal Investigator: Christian DEBRY, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP