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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00576134
First received: December 12, 2007
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles

Resource links provided by NLM:

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: February 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing
    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: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00576134     History of Changes
Other Study ID Numbers: 3866
Study First Received: December 12, 2007
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Larynx, tracheotomy, titanium beads

Additional relevant MeSH terms:
Neoplasms
Deglutition Disorders
Laryngeal Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
 Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013