NCT05079386

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

October 4, 2021

Last Update Submit

September 11, 2023

Conditions

Laryngectomy

Outcome Measures

Primary Outcomes (1)

  • Patient acceptability

    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 Outcomes (9)

  • Voice Assessment - Maximum phonation

    Baseline and 2 weeks

  • Voice Assessment - Highest volume

    Baseline and 2 weeks

  • Voice Assessment - Lowest Volume

    Baseline and 2 weeks

  • Voice Assessment - Softness

    Baseline and 2 weeks

  • Voice Assessment - Loudness

    Baseline and 2 weeks

  • +4 more secondary outcomes

Study Arms (1)

New Voice Prosthesis

EXPERIMENTAL

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

Interventions

New Voice ProsthesisDEVICE

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.

New Voice Prosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute: NKI

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (1)

  • Heirman AN, Tellman RS, van der Molen L, van Son R, van Sluis K, Halmos GB, Van den Brekel MWM, Dirven R. The acceptance and voice quality of a new voice prosthesis 'Vega High performance' - a feasibility study. Acta Otolaryngol. 2023 Aug;143(8):721-729. doi: 10.1080/00016489.2023.2241876. Epub 2023 Sep 1.

    PMID: 37656679RESULT

Study Officials

  • Michiel van den Brekel, Prof, MD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 15, 2021

Study Start

January 7, 2022

Primary Completion

January 27, 2023

Study Completion

January 27, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)