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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Laryngectomy; Status
• Intervention / Treatment: Device: Provox Vega Voice prosthesis

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital, CMU
  • Peking, China
    • Peking Union Medical College Hospital
  • Shanghai, China
    • Eye & ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Provox Vega Voice prosthesis; Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Evaluation of operative performance	Study-specific questionnaire on feasibility and satisfaction of clinicians	Baseline, 3 months, 6 months
Incidence of Adverse Events	Any adverse events (including serious adverse events and device defect rates) will be recorded.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Atos Medical AB
• Collaborators: Peking Union Medical College Hospital; Beijing Tongren Hospital; Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Gao Zhiqiang, Chief Physician, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Voice rehabilitation
• Other Study ID Numbers: AMAB-FYN-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No