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Bilateral Laryngeal Paralysis Reinnervation

This study is currently recruiting participants.
Verified by University Hospital, Rouen, May 2007

Sponsored by: University Hospital, Rouen
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213616
  Purpose

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.


Condition Intervention
Vocal Cord Paralysis
Procedure: surgical reinnervation

MedlinePlus related topics:   Paralysis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Bilateral Laryngeal Paralysis Reinnervation. Speech and Ventilatory Results Analysis

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • LARYNGEAL REINNERVATION

Estimated Enrollment:   10
Study Start Date:   March 2004

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Bilateral laryngeal paralysis without any amelioration for six months

Exclusion Criteria:

  • Laryngeal paralysis more than 3 years
  • Arycricoideus ankylostosis
  • Pacemaker
  • Pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213616

Contacts
Contact: Jean Paul Marie, MD, PHD     33 2 32 88 82 66     jean-paul.marie@chu-rouen.fr    

Locations
France
Rouen University Hospital     Recruiting
      ROUEN, France, 76031
      Contact: Jean Paul Marie, MD, PHD     33 2 32 88 82 66     jean-paul.marie@chu-rouen.fr    

Sponsors and Collaborators
University Hospital, Rouen

Investigators
Principal Investigator:     Jean Paul Marie, MD, PHD     Rouen University Hospital    
  More Information

Study ID Numbers:   99 - 141 HP
First Received:   September 13, 2005
Last Updated:   May 29, 2007
ClinicalTrials.gov Identifier:   NCT00213616
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:
bilateral vocal cord paralysis  
reinnervation  
phrenic nerve  

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Vocal Cord Paralysis
Neurologic Manifestations
Laryngeal Diseases

Additional relevant MeSH terms:
Vagus Nerve Diseases
Nervous System Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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