Laryngeal ParalysisNCT02969993
Very Long Term VHI Voice Outcome After MTIS
A study testing Questionnaires in people with Laryngeal Paralysis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in 2 countries.
Trial summary
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Laryngeal Paralysis
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2016to 19 Oct 2017
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
Cliniques universitaires Saint-Luc
Brussels Capital Region, Brussels Capital, 1200
CHU Namur -Mont-Godinne
Yvoir, Namur, 5530
Spain1 site
Valencia Medical School - Hospital General Universitario
Valencia, Levante, 46014
About this study
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale
- Conditions
- Laryngeal Paralysis
- Being tested
- Questionnaires
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
evaluating the voice outcome by the fullfilment of the voice handicap index
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Experimental | Questionnaire to previously operated patients Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice handicap index
Questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion17 Oct 2017
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal ParalysisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969993
- Sponsor's protocol ID
- 2016/394
- Status last verified
- Mar 2018
- First submitted
- 18 Nov 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Long Term VHI Voice Outcome After MTIS
- ClinicalTrials.gov ID
- NCT02969993
- Acronym / sponsor ID
- 2016/394
- Conditions
- Laryngeal Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 21 Nov 2016 (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.
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | Experimental | Other: QuestionnairesQuestionnaire to previously operated patients |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Questionnairesevaluating the voice outcome by the fullfilment of the voice handicap index | Other | Questionnaire |
Primary outcome
Voice handicap index
Time frame: 2 years
Questionnaire
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 20 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Laryngeal Paralysis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in 2 countries.
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 7 inclusion and 3 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Spain. 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?
Voice handicap index (time frame: 2 years). 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 20 Mar 2018.