Clinical trial NCT05482815: Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy
Official title: Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy: a Prospective, Multicenter, Self-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Laryngectomy; Status
Keywords: Voice rehabilitation
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
name: Beijing Tongren Hospital
name: Eye & ENT Hospital of Fudan University
First posted: 2022-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, multicenter, single-group test target trial design
Primary purpose: TREATMENT

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).


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
* Participated in other clinical trials within 1 month
* Other candidates the investigators think not appropriate

Primary outcomes:
measure: Change in pronunciation effect (subjective auditory assessment)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in longest articulation time (continuous /a/, count)
timeFrame: Baseline, 3 months, 6 months
measure: Change in sound intensity (minimum / maximum / comfortable);
timeFrame: Baseline, 3 months, 6 months
measure: Change in total time required to read a text
timeFrame: Baseline, 3 months, 6 months
measure: Change in Voice Handicap Index
timeFrame: Baseline, 3 months, 6 months
measure: Change in Quality of Life by SF-36
timeFrame: Baseline, 3 months, 6 months
measure: Evaluation of operative performance
timeFrame: Baseline, 3 months, 6 months
measure: Incidence of Adverse Events
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, CMU
city: Peking
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
Study officials:
affiliation: Peking Union Medical College Hospital
name: Gao Zhiqiang, Chief Physician
role: PRINCIPAL_INVESTIGATOR
References: