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Completed

NCT Number: NCT05079386

Clinical Feasibility 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.

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Key information

Conditions

Laryngectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Cancer Institute: NKI

Amsterdam, 1066 CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New Voice Prosthesis

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Voice Assessment - Highest volume

    Time frame: Baseline and 2 weeks

    Highest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.

  3. Voice Assessment - Lowest Volume

    Time frame: Baseline and 2 weeks

    Lowest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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).

  9. 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.

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • The Netherlands Cancer Institute

Registry information

Official study title

Early Clinical Feasibility Study of a New Voice Prosthesis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2021
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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