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Bilateral Laryngeal Paralysis Reinnervation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213616
First received: September 13, 2005
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bilateral Laryngeal Paralysis Reinnervation. Speech and Ventilatory Results Analysis

Resource links provided by NLM:

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • LARYNGEAL REINNERVATION [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

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

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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213616     History of Changes
Other Study ID Numbers: 1999/141/HP
Study First Received: September 13, 2005
Last Updated: February 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 22, 2013