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

Primary Purpose

Bilateral Vocal Fold Paralysis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgery for bilateral laryngeal reinnervation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Vocal Fold Paralysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Ongoing neoplasia disease
  • Cardiac pace maker
  • Pregnant woman or without contraception
  • Impairment of the freedom

Sites / Locations

  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with bilateral vocal fold paralysis

Arm Description

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).

Outcomes

Primary Outcome Measures

Maximal phonation time
Maximal phonation time will be assessed at 18 Months

Secondary Outcome Measures

Voice quality assessed using quality of life questionnaire
Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores
Voice quality assessed using computerized analysis
Voice quality will be assessed using computerized analysis
Voice quality assessed using swallowing scores
Voice quality will be assessed using swallowing scores

Full Information

First Posted
March 23, 2015
Last Updated
June 13, 2017
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02400008
Brief Title
Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis
Acronym
SEQLAR
Official Title
Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Vocal Fold Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with bilateral vocal fold paralysis
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Surgery for bilateral laryngeal reinnervation
Intervention Description
Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis
Primary Outcome Measure Information:
Title
Maximal phonation time
Description
Maximal phonation time will be assessed at 18 Months
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Voice quality assessed using quality of life questionnaire
Description
Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores
Time Frame
18 Months
Title
Voice quality assessed using computerized analysis
Description
Voice quality will be assessed using computerized analysis
Time Frame
18 Months
Title
Voice quality assessed using swallowing scores
Description
Voice quality will be assessed using swallowing scores
Time Frame
18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Ongoing neoplasia disease Cardiac pace maker Pregnant woman or without contraception Impairment of the freedom
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Paul MARIE, Pr
Phone
+3323288
Ext
6612
Email
jean-paul.marie@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul MARIE, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul MARIE, Pr
Email
jean-paul.marie@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Jean-Paul MARIE, Pr

12. IPD Sharing Statement

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

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