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

NCT ID: NCT05482815

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2024-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Provox Vega Voice prosthesis

Intervention Type: DEVICE

Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis

Interventions

Provox Vega Voice prosthesis

Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Atos Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gao Zhiqiang, Chief Physician

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Beijing Tongren Hospital, CMU

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Eye & ENT Hospital of Fudan University

Shanghai, , China

Countries

China

Other Identifiers

AMAB-FYN-1.0

Identifier Type: -

Identifier Source: org_study_id