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Clinical Feasibility of a New Voice Prosthesis

NCT05079386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-09-13

No results posted yet for this study

Summary

The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.

Conditions

  • Laryngectomy

Interventions

DEVICE

New Voice Prosthesis

Replacement of the current prosthesis with the experimental device and use the New Voice Prosthesis for the duration of two weeks with the option of leaving the device in situ until replaced for device failure or other reason, with a maximum of 12 months.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Atos Medical AB

    lead INDUSTRY

Principal Investigators

  • Michiel van den Brekel, Prof, MD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2023-01-27
Completion
2023-01-27

Countries

  • Netherlands

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 NCT05079386 on ClinicalTrials.gov