The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement

This study is currently recruiting participants.

Verified by University Hospital, Strasbourg, France, February 2009

First Received: December 12, 2007 Last Updated: February 24, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Swallowing Disorders

U.S. FDA Resources

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:	January 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	January 2013 (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

No publications provided

Responsible Party:	Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg ( Christine GEILLER )
Study ID Numbers:	3866
Study First Received:	December 12, 2007
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00576134 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Strasbourg, France:

Larynx, tracheotomy, titanium beads

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Gastrointestinal Diseases
Laryngeal Neoplasms
Pharyngeal Diseases
Deglutition Disorders

Neoplasms
Digestive System Diseases
Neoplasms by Site
Respiratory Tract Diseases
Head and Neck Neoplasms
Esophageal Diseases
Laryngeal Diseases

ClinicalTrials.gov processed this record on November 27, 2009