Clinical Feasibility of a New Voice Prosthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2023-01-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Laryngectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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New Voice Prosthesis

Patients will use the New Voice Prosthesis for two weeks to investigate short term feasibility and explore limitations and advantages. If the patient wishes to leave the New Voice Prosthesis in situ, this will be allowed under the condition that the subject agrees to remain in the study and report (adverse) events on an ongoing basis, until the device is removed after a maximum of 12 months.

Group Type EXPERIMENTAL

New Voice Prosthesis

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
* 18 years and older

Exclusion Criteria

* Current tracheoesophageal puncture problems such as enlarged puncture or infection
* Active recurrent or metastatic disease (medical deterioration)
* The use of ActiValve Strong/XtraStrong or XtraSeal
* Unable to understand the Patient Information and/or unable to give Informed Consent
* The previous 2 VPs had a device lifetime \> 12 months
* History of oral resections negatively affecting speech

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No