Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy
- Conditions
- Laryngectomy; Status
- Interventions
- Device: Provox Vega Voice prosthesis
- Registration Number
- NCT05482815
- Lead Sponsor
- Atos Medical AB
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Voice Prosthesis Provox Vega Voice prosthesis 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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.
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.
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 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).
Evaluation of operative performance Baseline, 3 months, 6 months Study-specific questionnaire on feasibility and satisfaction of clinicians
Trial Locations
- Locations (3)
Eye & ENT Hospital of Fudan University
🇨🇳Shanghai, China
Beijing Tongren Hospital, CMU
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Peking, China