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Sponsors and Collaborators: |
University Hospital, Strasbourg, France OseoAnvar Réseau National des Technologies de Santé |
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Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00396617 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy |
Estimated Enrollment: | 14 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | November 2011 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: Christian DEBRY, MD | 33.3.88.12.76.44 | christian.debry@chru-strasbourg.fr |
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 |
Principal Investigator: | Christian DEBRY, MD | Hôpitaux Universitaires de Strasbourg |
Responsible Party: | University Hospital, Strasbourg, France ( Emmanuel LAVOUE, Directeur Adjoint ) |
Study ID Numbers: | 3736 |
Study First Received: | November 6, 2006 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00396617 |
Health Authority: | France: Ministry of Health |
Laryngeal or pharyngo-laryngeal's carcinoma, voice prosthesis tracheooesophageal shunt, titanium beads, cellular colonization Specify the primary condition or disease being studied : Laryngeal or pharyngo-laryngeal's carcinoma |
Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Head and Neck Neoplasms Laryngeal carcinoma Pharyngeal Neoplasms |
Laryngeal Neoplasms Stomatognathic Diseases Laryngeal Diseases Pharyngeal Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |