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

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

February 24, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00576134 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Swallowing Disorders
Dysphagia
Laryngeal Neoplasms

Intervention ^ICMJE

Device: Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Age more than 18
Swallowing troubles

Exclusion criteria:

Pregnant women
Contraindications to general anesthesia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christian DEBRY, MD

33.3.88.12.76.45

christian.debry@chru-strasbourg.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00576134

Responsible Party

Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Study ID Numbers ^ICMJE

3866

Study Sponsor ^ICMJE

University Hospital, Strasbourg, France

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christian DEBRY, MD

Hôpitaux Universitaires de Strasbourg

Information Provided By

University Hospital, Strasbourg, France

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP