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NCT00213616 Clinical Trial

Bilateral Laryngeal Paralysis Reinnervation

Vocal Cord Paralysis Clinical Trial

Official title:
Bilateral Laryngeal Paralysis Reinnervation. Speech and Ventilatory Results Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00213616
Other study ID # 1999/141/HP
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated June 17, 2013
Start date March 2004
Est. completion date January 2011

Study information
Verified date June 2013
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Bilateral laryngeal paralysis without any amelioration for six months

Exclusion Criteria:

- Laryngeal paralysis more than 3 years

- Arycricoideus ankylostosis

- Pacemaker

- Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• surgical reinnervation
laryngeal reinnervation with a phrenic nerve root

Locations
Country Name City State
France Rouen University Hospital Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary LARYNGEAL REINNERVATION 6 months No
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