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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: December 12, 2007
Last updated: January 22, 2015
Last verified: January 2015
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
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

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 ]

Enrollment: 10
Study Start Date: February 2008
Study Completion Date: August 2013
Primary Completion Date: August 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Age more than 18
  • Swallowing troubles

Exclusion criteria:

  • Pregnant women
  • Contraindications to general anesthesia
  Contacts and Locations
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Please refer to this study by its identifier: NCT00576134

Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Christian DEBRY, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00576134     History of Changes
Other Study ID Numbers: 3866
Study First Received: December 12, 2007
Last Updated: January 22, 2015
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:
Deglutition Disorders
Laryngeal Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Laryngeal Diseases
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms processed this record on November 27, 2015