Bilateral Vocal Fold ParalysisSEQLARNCT02400008
Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis
A study testing Surgery for bilateral laryngeal reinnervation in people with Bilateral Vocal Fold Paralysis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bilateral Vocal Fold Paralysis
- What is being tested?
- Surgery for bilateral laryngeal reinnervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2014to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before.
- 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
Who cannot join
- Long term vocal fold paralysis (more than 3 years with strong denervation)
- Ary-cricoid ankylosis or synechiae
- Age >75 years
- Anaesthesiologist contra indication
- Strong respiratory disease history
- Severe coagulation troubles
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- Ongoing neoplasia disease
- Cardiac pace maker
- Pregnant woman or without contraception
- Impairment of the freedom
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results
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.
Read more
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
- Bilateral Vocal Fold Paralysis
- Being tested
- Surgery for bilateral laryngeal reinnervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for bilateral laryngeal reinnervationProcedure or surgery
Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis
| Study group | Role | What they receive |
|---|---|---|
| Patient with bilateral vocal fold paralysis | Experimental | 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). Receives: Procedure: Surgery for bilateral laryngeal reinnervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal phonation time
Maximal phonation time will be assessed at 18 Months
Measured: 18 Months
Secondary outcomes (3)
Voice quality assessed using quality of life questionnaire
Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores
Measured: 18 Months
Voice quality assessed using computerized analysis
Voice quality will be assessed using computerized analysis
Measured: 18 Months
Voice quality assessed using swallowing scores
Voice quality will be assessed using swallowing scores
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study start9 Nov 2014
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Vocal Fold ParalysisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul MARIE, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400008
- Sponsor's protocol ID
- 2011/120/HP
- Acronym
- SEQLAR
- Status last verified
- Jan 2026
- First submitted
- 23 Mar 2015
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results
- ClinicalTrials.gov ID
- NCT02400008
- Acronym / sponsor ID
- SEQLAR / 2011/120/HP
- Conditions
- Bilateral Vocal Fold Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Nov 2014 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with bilateral vocal fold paralysis | Experimental | Procedure: Surgery for bilateral laryngeal reinnervationPatient 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before.
- 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
Key exclusion criteria (10 listed)
- Long term vocal fold paralysis (more than 3 years with strong denervation)
- Ary-cricoid ankylosis or synechiae
- Age >75 years
- Anaesthesiologist contra indication
- Strong respiratory disease history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for bilateral laryngeal reinnervationSurgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis | Procedure or surgery | Patient with bilateral vocal fold paralysis |
Primary outcome
Maximal phonation time
Time frame: 18 Months
Maximal phonation time will be assessed at 18 Months
3 secondary outcomes
Voice quality assessed using quality of life questionnaire
Time frame: 18 Months
Voice quality assessed using computerized analysis
Time frame: 18 Months
Voice quality assessed using swallowing scores
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Related trials for Bilateral Vocal Fold Paralysis
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Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx
Bilateral Vocal Fold Paralysis (BVFP)
RecruitingObservational study
Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
Bilateral Vocal Cord Paralysis
Active, not recruiting
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord Paralysis
Not yet recruiting
Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)
Vocal Cord Paralysis, Bilateral, Airway Obstruction, Postoperative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul MARIE, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery for bilateral laryngeal reinnervation in people with Bilateral Vocal Fold Paralysis, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal phonation time (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.