Bilateral Laryngeal Paralysis Reinnervation
Primary Purpose
Vocal Cord Paralysis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surgical reinnervation
Sponsored by
About this trial
This is an interventional treatment trial for Vocal Cord Paralysis focused on measuring bilateral vocal cord paralysis, reinnervation, phrenic nerve
Eligibility Criteria
Inclusion Criteria: Bilateral laryngeal paralysis without any amelioration for six months Exclusion Criteria: Laryngeal paralysis more than 3 years Arycricoideus ankylostosis Pacemaker Pregnancy
Sites / Locations
- Rouen University Hospital
Outcomes
Primary Outcome Measures
LARYNGEAL REINNERVATION
Secondary Outcome Measures
Full Information
NCT ID
NCT00213616
First Posted
September 13, 2005
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00213616
Brief Title
Bilateral Laryngeal Paralysis Reinnervation
Official Title
Bilateral Laryngeal Paralysis Reinnervation. Speech and Ventilatory Results Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve root to patients with bilateral laryngeal paralysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Paralysis
Keywords
bilateral vocal cord paralysis, reinnervation, phrenic nerve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
surgical reinnervation
Intervention Description
laryngeal reinnervation with a phrenic nerve root
Primary Outcome Measure Information:
Title
LARYNGEAL REINNERVATION
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral laryngeal paralysis without any amelioration for six months
Exclusion Criteria:
Laryngeal paralysis more than 3 years
Arycricoideus ankylostosis
Pacemaker
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Paul Marie, MD, PHD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Bilateral Laryngeal Paralysis Reinnervation
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