Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Phase 1

• Conditions: Pharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma

• Registration Number: NCT00396617
• Lead Sponsor: University Hospital, Strasbourg, France

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 Description

Not available

Study Timeline

• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-06
• Study First Posted: 2006-11-07
• Study Start: 2007-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02
• Primary Completion: 2013-09
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Phonology's measures	months 1, 3,12

Trial Locations

Locations (1)

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France