The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China. Main outcome will be the assessment of pronunciation effect (subjective auditory assessment).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis
Beijing Tongren Hospital, CMU
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Eye & ENT Hospital of Fudan University
Shanghai, China
Change in pronunciation effect (subjective auditory assessment)
Voice recordings judged by two independent evaluators, scored from 1-7, with lower scores meaning worse speech.
Time frame: Baseline, 3 months, 6 months
Change in longest articulation time (continuous /a/, count)
The longest duration time of one continuous / a / is recorded by a stopwatch, count and the average of three times are taken at the same time.
Time frame: Baseline, 3 months, 6 months
Change in sound intensity (minimum / maximum / comfortable);
Sound intensity of the minimum / maximum / comfortable loudness (measured 3 times per person) is recorded to calculate the dynamic range (in decibels)
Time frame: Baseline, 3 months, 6 months
Change in total time required to read a text
Standard Chinese text is read out loud, and the total time is recorded.
Time frame: Baseline, 3 months, 6 months
Change in Voice Handicap Index
Validated tool to assess Voice handicap. Statements on participant's voice quality and effect on social life are assessed by a five-point Likert-scale, ranged from 0-4, with high scores indicating more handicap (0 = Never, 4 = Always).
Time frame: Baseline, 3 months, 6 months
Change in Quality of Life by SF-36
Patient reported, 36-item, Score of calculated, ranging from 0-100, the lower the score the more disability. The higher the score the less disability
Time frame: Baseline, 3 months, 6 months
Evaluation of operative performance
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Study-specific questionnaire on feasibility and satisfaction of clinicians
Time frame: Baseline, 3 months, 6 months
Incidence of Adverse Events
Any adverse events (including serious adverse events and device defect rates) will be recorded.
Time frame: Baseline, 3 months, 6 months