Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy: a Prospective, Multicenter, Self-controlled Clinical Trial

Conditions
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Laryngectomy; Status

Intervention / Treatment
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* Device: Provox Vega Voice prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age is greater than 18 years; the gender is not limited Performed total laryngectomy; No voice prosthesis has been installed Be able to take care of themselves mentally and physically, and have good hand coordination ability With healthy wall sharing with trachea and esophagus The patient has a desire to restore articulation function Can speak Mandarin and have a certain reading ability (equivalent to primary school education) The subject is fully aware of the benefits and risks of this trial and is willing to participate in and sign the informed consent form Exclusion Criteria: There is serious respiratory system disease or defect There is a serious skin disease in the tracheostoma Obvious intelligence and mental disorder Tracheostoma is narrow and needs cannula implantation Patients with limitation of mouth opening and other subjects with dyslalia or language disorders (such as subjects with sequelae of cerebral infarction, etc.) Patients with severe respiratory disease, cardiopulmonary disease (e.g., severe arrhythmia, persons with slow ventricular rate (ventricular rate <50 beats/ min), acute phase of myocardial infarction and severe heart failure), disturbances of blood coagulation (coagulation index PT, APTT, INR> 1.5 times of the normal upper limit), septicemia and other patients not suitable Patients with severe diseases of liver and renal function (liver function index, alanine aminotransferase (ALT), aspartate aminotransferase (AST)> 2 times of normal upper limit, renal function index, urine creatinine (Cr), blood urea nitrogen (BUN)> 2 times of normal upper limit); Patients with local recurrence of tumor or metastatic tumor If the patient has received esophageal articulation training, the time of training and using esophagus to speech should be less than 6 months Women planning to have child, in lactation or pregnancy during the whole clinical study Participated in other clinical trials within 1 month Other candidates the investigators think not appropriate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, multicenter, single-group test target trial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voice Prosthesis<br>Subjects receive a Voice prosthesis using the Provox Puncture Set, then undergo an articulation training program (3 weeks). The voice prosthesis is replaced after 3 months and 6 months. | Device: Provox Vega Voice prosthesis<br>* Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pronunciation effect (subjective auditory assessment) | Voice recordings judged by two independent evaluators, scored from 1-7, with lower scores meaning worse speech. | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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). | 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 | Baseline, 3 months, 6 months | 
| Evaluation of operative performance | Study-specific questionnaire on feasibility and satisfaction of clinicians | Baseline, 3 months, 6 months | 
| Incidence of Adverse Events | Any adverse events (including serious adverse events and device defect rates) will be recorded. | Baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Voice rehabilitation