Clinical Trial: Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Brief 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

Detailed Summary:
Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: 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 ]

Original Primary Outcome: Clinical measures concerning peri and intra prosthetic leakage- days 8,15,21,30-months : 2,3,4,6,15,18,21,24,30

Current Secondary Outcome: Phonology's measures [ Time Frame: months 1, 3,12 ]

Original Secondary Outcome: Phonology's measures - months 1, 3,12

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: November 6, 2006
Date Started: December 2007
Date Completion: March 2014
Last Updated: June 28, 2012
Last Verified: June 2012