Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Lar… (NCT05482815) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy
China80 participantsStarted 2021-05-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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), asparta…
What they're measuring
1
Change in pronunciation effect (subjective auditory assessment)