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

NCT05482815 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-09-13

No results posted yet for this study

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

Interventions

DEVICE

Provox Vega Voice prosthesis

Voice prosthesis for speech rehabilitation, Provox Vega Voice prosthesis

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Beijing Tongren Hospital

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    collaborator OTHER

  • Atos Medical AB

    lead INDUSTRY

Principal Investigators

  • Gao Zhiqiang, Chief Physician · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482815 on ClinicalTrials.gov