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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00576134
First received: December 12, 2007
Last updated: January 22, 2015
Last verified: January 2015

December 12, 2007
January 22, 2015
February 2008
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00576134 on ClinicalTrials.gov Archive Site
Nasofibroscopy [ Time Frame: Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement
Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Swallowing Disorders
  • Dysphagia
  • Laryngeal Neoplasms
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Age more than 18
  • Swallowing troubles

Exclusion criteria:

  • Pregnant women
  • Contraindications to general anesthesia
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00576134
3866
No
Not Provided
Not Provided
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Christian DEBRY, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
January 2015

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