Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy

Laryngectomy; Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05482815
• Other study ID #: AMAB-FYN-1.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2023
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngectomy; Status

Intervention

Device:
• Provox Vega Voice prosthesis
Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, CMU	Beijing
China	Peking Union Medical College Hospital	Peking
China	Eye & ENT Hospital of Fudan University	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Atos Medical AB	Beijing Tongren Hospital, Eye & ENT Hospital of Fudan University, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in sound intensity (minimum / maximum / comfortable);	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluation of operative performance	Study-specific questionnaire on feasibility and satisfaction of clinicians	Baseline, 3 months, 6 months
Secondary	Incidence of Adverse Events	Any adverse events (including serious adverse events and device defect rates) will be recorded.	Baseline, 3 months, 6 months