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

NCT05482815 | Unknown

• 1 other identifier: AMAB-FYN-1.0
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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).

Conditions

Laryngectomy; Status

Keywords

Voice rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in longest articulation time (continuous /a/, count)

  Baseline, 3 months, 6 months

• Change in sound intensity (minimum / maximum / comfortable);

  Baseline, 3 months, 6 months

• Change in total time required to read a text

  Baseline, 3 months, 6 months

• Change in Voice Handicap Index

  Baseline, 3 months, 6 months

• Change in Quality of Life by SF-36

  Baseline, 3 months, 6 months

Study Arms (1)

Voice Prosthesis

EXPERIMENTAL

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

Interventions

Provox Vega Voice prosthesis DEVICE

Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis

Voice Prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atos Medical AB: lead
• Peking Union Medical College Hospital: collaborator
• Beijing Tongren Hospital: collaborator
• Eye & ENT Hospital of Fudan University: collaborator

Study Sites (3)

Beijing Tongren Hospital, CMU

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, China

Location

Study Officials

• Gao Zhiqiang, Chief Physician

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, single-group test target trial design

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 1, 2022
• Study Start: May 5, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)