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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Beijing Tongren Hospital | OTHER |
| Eye & ENT Hospital of Fudan University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voice Prosthesis | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provox Vega Voice prosthesis | Device | Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis |
|
| 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 |
| 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); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gao Zhiqiang, Chief Physician | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, CMU | Beijing | China | ||||
| Peking Union Medical College Hospital |
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prospective, multicenter, single-group test target trial design
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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 |
| Beijing |
| China |
| Eye & ENT Hospital of Fudan University | Shanghai | China |