Clinical Trials Directory

Trials / Completed

CompletedNCT02400008

Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis

Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis. The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides. Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol). Improvement is expected in voice and breathing, without aspiration.

Conditions

Interventions

TypeNameDescription
PROCEDURESurgery for bilateral laryngeal reinnervationSurgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis

Timeline

Start date
2014-11-09
Primary completion
2021-10-15
Completion
2021-10-15
First posted
2015-03-26
Last updated
2026-01-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02400008. Inclusion in this directory is not an endorsement.