The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement - Full Text View

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00576134

Purpose

Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. The secondary objective is to study the concept of a special valves system for the development of an artificial larynx

Condition	Intervention	Phase
Swallowing Disorders Dysphagia Laryngeal Neoplasms	Device: Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing	Phase I

MedlinePlus related topics: Cancer Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

Respiratory evaluation [ Time Frame: Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Nasofibroscopy [ Time Frame: Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

An artificial Larynx composed of a tracheobronxane ® Dumon ST prosthesis and a valves system will be implant under general anesthesia by endoscopy. The 3 first patients will be patients with tracheotomy, in order to allow breathing through this tracheotomy in case of valves dysfunction.

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
Swallowing troubles

Exclusion criteria:

Pregnant women
Contraindications to general anesthesia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576134

Contacts

Contact: Christian DEBRY, MD

33.3.88.12.76.45

christian.debry@chru-strasbourg.fr

Locations

France
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière	Recruiting
STRASBOURG, France, 67098
Contact: Christian DEBRY, MD 33.3.88.12.76.45 christian.debry@chru-strasbourg.fr
Principal Investigator: Christian DEBRY, MD
Sub-Investigator: Patrick HEMAR, MD
Sub-Investigator: Philippe SCHULTZ, MD
Sub-Investigator: Anne CHARPIOT, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Christian DEBRY, MD

Hôpitaux Universitaires de Strasbourg

More Information

Responsible Party:	Emmanuel LAVOUE, Directeur Adjoint de la DRCI ( University Hospital, Strasbourg, France )
Study ID Numbers:	3866
Study First Received:	December 12, 2007
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00576134
Health Authority:	France: AFSSAPS

Keywords provided by University Hospital, Strasbourg, France:

Larynx, tracheotomy, titanium beads

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Laryngeal Neoplasms
Pharyngeal Diseases
Deglutition Disorders

Digestive System Diseases
Respiratory Tract Diseases
Head and Neck Neoplasms
Laryngeal carcinoma
Esophageal Diseases
Laryngeal Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009