Laryngectomy; Status
Conditions
Keywords
Voice rehabilitation
Brief summary
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).
Interventions
DEVICEProvox Vega Voice prosthesis
Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis
Sponsors
Peking Union Medical College Hospital
Beijing Tongren Hospital
Eye & ENT Hospital of Fudan University
Atos Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, multicenter, single-group test target trial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pronunciation effect (subjective auditory assessment) | Baseline, 3 months, 6 months | Voice recordings judged by two independent evaluators, scored from 1-7, with lower scores meaning worse speech. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sound intensity (minimum / maximum / comfortable); | Baseline, 3 months, 6 months | Sound intensity of the minimum / maximum / comfortable loudness (measured 3 times per person) is recorded to calculate the dynamic range (in decibels) |
| Change in total time required to read a text | Baseline, 3 months, 6 months | Standard Chinese text is read out loud, and the total time is recorded. |
| Change in Voice Handicap Index | Baseline, 3 months, 6 months | 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). |
| Change in longest articulation time (continuous /a/, count) | Baseline, 3 months, 6 months | 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. |
| Evaluation of operative performance | Baseline, 3 months, 6 months | Study-specific questionnaire on feasibility and satisfaction of clinicians |
| Incidence of Adverse Events | Baseline, 3 months, 6 months | Any adverse events (including serious adverse events and device defect rates) will be recorded. |
| Change in Quality of Life by SF-36 | Baseline, 3 months, 6 months | 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 |
Countries
China
Outcome results
None listed