- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969993
Very Long Term VHI Voice Outcome After MTIS
March 19, 2018 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale
Study Overview
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients presenting UVFP of neurogenic origin treated by MTIS > 2 years before inclusion.
- No superior limit in terms of years.
- Age 18-80 years at the time of MTIS
- No other treatment before MTIS other than resorbing material injection laryngoplasty (maximum twice)
- No further voice treatment after MTIS except speech therapy.
- VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into account
- VHI tests validated for the utilized language
Exclusion Criteria:
- patient not able to answer VHI questionnaire personally
- Post MTIS new health condition affecting the voice tract and/ or the respiratory function.
- Post MTIS appearance of other voice/ vocal cord pathology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Questionnaire
Questionnaire to previously operated patients
|
evaluating the voice outcome by the fullfilment of the voice handicap index
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Voice handicap index
Time Frame: 2 years
|
Questionnaire
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Actual)
October 17, 2017
Study Completion (Actual)
October 19, 2017
Study Registration Dates
First Submitted
November 18, 2016
First Submitted That Met QC Criteria
November 18, 2016
First Posted (Estimate)
November 21, 2016
Study Record Updates
Last Update Posted (Actual)
March 20, 2018
Last Update Submitted That Met QC Criteria
March 19, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/394
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Laryngeal Paralysis
-
Lütfiye Nuri Burat Government HospitalUnknownVocal Cord Paralysis | Recurrent Laryngeal NerveTurkey
-
Northwell HealthRecruitingVocal Cord Paralysis | Vocal Cord Dysfunction | Recurrent Laryngeal Nerve Injuries | Vocal Cord Paresis | Recurrent Laryngeal Nerve PalsyUnited States
-
MED-EL Elektromedizinische Geräte GesmbHRecruitingBilateral Vocal Cord ParalysisAustria, Germany
-
Cliniques universitaires Saint-Luc- Université...Active, not recruitingUnilateral Vocal Cord ParalysisBelgium
-
Royal National Throat, Nose and Ear HospitalUniversity College London Hospitals; University College Joint Research Office; NIHR Research for Patient Benefit (RfPB) and other collaboratorsCompletedVocal Cord Paralysis UnilateralUnited Kingdom
-
National Institute on Deafness and Other Communication...Terminated
-
Pak Emirates Military HospitalCompletedParalysis of Vocal Cords or Larynx | Bilateral Vocal Cord ParalysisPakistan
-
University of California, San FranciscoNational Spasmodic Dysphonia AssociationNot yet recruitingVocal Cord Paralysis | Globus Pharyngeus | Spasmodic Dysphonia | Aspiration | Laryngeal Disease | Presbylarynx | Sensory Neuropathy | Iatrogenic Injury | Larynx ParalysisUnited States
-
APrevent Biotech GmbHCompletedParalysis, Unilateral, Vocal CordAustria
-
Chang Gung Memorial HospitalUnknownUnilateral Vocal Cord ParalysisTaiwan
Clinical Trials on Questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Sun Yat-sen UniversityNot yet recruiting
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount Sinai; Hackensack Meridian Health; Derald H...CompletedLeukemia | Multiple Myeloma | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States