Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis
NCT ID: NCT02400008
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2014-11-09
2021-10-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patient with bilateral vocal fold paralysis
Patient with bilateral vocal fold paralysis in a closure position between 6 months to 36 months before et who has been treated by endoscopic treatment without satisfying result (voice or breathing).
Surgery for bilateral laryngeal reinnervation
Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis
Interventions
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Surgery for bilateral laryngeal reinnervation
Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis
Eligibility Criteria
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Inclusion Criteria
* Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing).
* Patient with passive mobile arytenoid at least on one side
* Tracheostomized or not
* Age \> 18 years old
* Good general situation
Exclusion Criteria
* Ary-cricoid ankylosis or synechiae
* Age \>75 years
* Anaesthesiologist contra indication
* Strong respiratory disease history
* Severe coagulation troubles
* Ongoing neoplasia disease
* Cardiac pace maker
* Pregnant woman or without contraception
* Impairment of the freedom
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Jean-Paul MARIE, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2011/120/HP
Identifier Type: -
Identifier Source: org_study_id
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