Clinical Feasibility of a New Voice Prosthesis

Laryngectomy Clinical Trial

Official title:

Early Clinical Feasibility Study of a New Voice Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05079386
• Other study ID #: N21VEG
• Status: Completed
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: January 27, 2023

Study information

• Verified date: September 2023
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngectomy

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute: NKI	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Atos Medical AB	The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

References & 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 Sep 1:1-9. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Voice Assessment - Maximum phonation	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
Secondary	Voice Assessment - Highest volume	Highest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.	Baseline and 2 weeks
Secondary	Voice Assessment - Lowest Volume	Lowest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.	Baseline and 2 weeks
Secondary	Voice Assessment - Softness	Speaking as soft as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.	Baseline and 2 weeks
Secondary	Voice Assessment - Loudness	Speaking as loud as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.	Baseline and 2 weeks
Secondary	Voice Assessment - Glide tones	Successful completion of glide town, from low to high. Assessed with current Voice Prosthesis and the New Voice Prosthesis.	Baseline and 2 weeks
Secondary	Quality of Life by EQ-5D-5L	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
Secondary	Voice Handicap Index - 10	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
Secondary	Device life	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