The Objective is to Utilize the Potential of Porous Titanium to Respond to Patients' Needs in the Field of Phonatory Implant Insertion - Full Text View

Sponsors and Collaborators:	University Hospital, Strasbourg, France OseoAnvar Réseau National des Technologies de Santé
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00396617

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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:	October 2006
Estimated Study Completion Date:	November 2011

Intervention Details:

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.

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

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

Keywords provided by University Hospital, Strasbourg, France:

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009