Clinical Feasibility of a New Voice Prosthesis

September 11, 2023 updated by: Atos Medical AB

Early Clinical Feasibility Study of a New Voice Prosthesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute: NKI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient acceptability
Time Frame: 2 week
Patient recorded acceptability of the voice prosthesis based on study specific questionnaires covering: 1) Experienced stickiness, 2) Effort to speak and 3) maintenance of voice prosthesis. Assessed by Yes/No and multiple choice questions.
2 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Assessment - Maximum phonation
Time Frame: Baseline and 2 weeks
Longest maximum phonation time in seconds out of 2 consecutive attempts. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Baseline and 2 weeks
Voice Assessment - Highest volume
Time Frame: Baseline and 2 weeks
Highest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Baseline and 2 weeks
Voice Assessment - Lowest Volume
Time Frame: Baseline and 2 weeks
Lowest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Baseline and 2 weeks
Voice Assessment - Softness
Time Frame: Baseline and 2 weeks
Speaking as soft as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Baseline and 2 weeks
Voice Assessment - Loudness
Time Frame: Baseline and 2 weeks
Speaking as loud as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Baseline and 2 weeks
Voice Assessment - Glide tones
Time Frame: Baseline and 2 weeks
Successful completion of glide town, from low to high. Assessed with current Voice Prosthesis and the New Voice Prosthesis.
Baseline and 2 weeks
Quality of Life by EQ-5D-5L
Time Frame: Baseline and 2 weeks
Patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility
Baseline and 2 weeks
Voice Handicap Index - 10
Time Frame: Baseline and 2 weeks
Validated tool to assess Voice handicap. Statements on participant's voice quality and effect on social life are assessed by a five-point Likert-scale, ranged from 0-4, with high scores indicating more handicap (0 = Never, 4 = Always).
Baseline and 2 weeks
Device life
Time Frame: Baseline, and week 52
Device life of two previous Voice prosthesis and device life of the New Voice Prosthesis in the long-term part of study.
Baseline, and week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atos Medical AB

Collaborators

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Michiel van den Brekel, Prof, MD, The Netherlands Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

January 27, 2023

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • N21VEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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