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Bilateral Laryngeal Paralysis Reinnervation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213616
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bilateral Laryngeal Paralysis Reinnervation. Speech and Ventilatory Results Analysis

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • LARYNGEAL REINNERVATION [ Time Frame: 6 months ]

Enrollment: 10
Study Start Date: March 2004
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: surgical reinnervation
    laryngeal reinnervation with a phrenic nerve root
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213616


Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Jean Paul Marie, MD, PHD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213616     History of Changes
Other Study ID Numbers: 1999/141/HP
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Paralysis
Vocal Cord Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases