Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

Study Overview
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Brief Summary
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The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.

Official Title
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Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.

Conditions
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Total Laryngectomy

Intervention / Treatment
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* Device: Provox voice prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total laryngectomy Use Provox ActiValve Exclusion Criteria: Current problems with TE puncture

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Provox voice prosthesis<br> | Device: Provox voice prosthesis<br>* The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted<br>* Other names: Indwelling voice prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term Feasibility Provox Vega 22.5 French | Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Voice and Speech Quality | Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20. | 3 weeks | 
| Device Life Time | Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.) | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngectomy, larynx cancer