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Bilateral Laryngeal Paralysis Reinnervation

Primary Purpose

Vocal Cord Paralysis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surgical reinnervation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
June 17, 2013
Sponsor
University Hospital, Rouen
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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

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Bilateral Laryngeal Paralysis Reinnervation

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