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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576134
First Posted: December 18, 2007
Last Update Posted: January 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Nasofibroscopy [ Time Frame: Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36 ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age more than 18
  • Swallowing troubles

Exclusion criteria:

  • Pregnant women
  • Contraindications to general anesthesia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576134


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

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00576134     History of Changes
Other Study ID Numbers: 3866
First Submitted: December 12, 2007
First Posted: December 18, 2007
Last Update Posted: January 26, 2015
Last Verified: January 2015

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

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