Very Long Term VHI Voice Outcome After MTIS NCT02969993

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

Study information
Verified date	March 2018
Source	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale

Recruitment information / eligibility
Status	Completed
Enrollment	53
Est. completion date	October 19, 2017
Est. primary completion date	October 17, 2017
Accepts healthy volunteers	No
Gender	All
Age group	16 Years to 80 Years
Eligibility	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

Other:
• Questionnaires
evaluating the voice outcome by the fullfilment of the voice handicap index

Locations
Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels Capital Region	Brussels
Belgium	CHU Namur -Mont-Godinne	Yvoir	Namur
Spain	Valencia Medical School - Hospital General Universitario	Valencia	Levante

Sponsors *(1)*
Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Belgium, Spain,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Voice handicap index	Questionnaire	2 years