Back to resultsThe Objective is to Respond to Patients' Needs in the Field of Larynx Replacement
Primary Purpose
Swallowing Disorders, Dysphagia, Laryngeal Neoplasms
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing
Sponsored by
About this trial
This is an interventional treatment trial for Swallowing Disorders focused on measuring Larynx, tracheotomy, titanium beads
Eligibility Criteria
Inclusion criteria:
- Age more than 18
- Swallowing troubles
Exclusion criteria:
- Pregnant women
- Contraindications to general anesthesia
Sites / Locations
- Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
Outcomes
Primary Outcome Measures
Respiratory evaluation
Secondary Outcome Measures
Nasofibroscopy
Full Information
NCT ID
NCT00576134
First Posted
December 12, 2007
Last Updated
January 22, 2015
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00576134
Brief Title
The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement
Official Title
Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorders, Dysphagia, Laryngeal Neoplasms
Keywords
Larynx, tracheotomy, titanium beads
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Implantation of intralaryngeal prosthesis with a new double valve system, allowing tracheotomy closing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory evaluation
Time Frame
Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36
Secondary Outcome Measure Information:
Title
Nasofibroscopy
Time Frame
Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age more than 18
Swallowing troubles
Exclusion criteria:
Pregnant women
Contraindications to general anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian DEBRY, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière
City
Strasbourg
ZIP/Postal Code
67098
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement
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