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

Atos Medical AB3 sites in 1 country80 target enrollmentMay 5, 2021

ConditionsLaryngectomy; Status

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Laryngectomy; Status
Sponsor: Atos Medical AB
Enrollment: 80
Locations: 3
Primary Endpoint: Change in pronunciation effect (subjective auditory assessment)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 5, 2021

End Date

January 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Atos Medical AB

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in pronunciation effect (subjective auditory assessment)

Time Frame: Baseline, 3 months, 6 months

Voice recordings judged by two independent evaluators, scored from 1-7, with lower scores meaning worse speech.

Secondary Outcomes

Change in sound intensity (minimum / maximum / comfortable);(Baseline, 3 months, 6 months)
Change in Quality of Life by SF-36(Baseline, 3 months, 6 months)
Change in longest articulation time (continuous /a/, count)(Baseline, 3 months, 6 months)
Change in total time required to read a text(Baseline, 3 months, 6 months)
Incidence of Adverse Events(Baseline, 3 months, 6 months)
Change in Voice Handicap Index(Baseline, 3 months, 6 months)
Evaluation of operative performance(Baseline, 3 months, 6 months)