Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis

Study Overview
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Brief Summary
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The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.

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

Conditions
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Total Laryngectomy

Intervention / Treatment
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* Device: Provox Vega voice prosthesis (20 Fr)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: total laryngectomy use Provox2 voice prosthesis at least two prior prosthesis changes Exclusion Criteria: current puncture problems (f. ex. infection)
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: Early feasability arm<br> | Device: Provox Vega voice prosthesis (20 Fr)<br>* The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system<br>* Other names: indwelling Provox voice prosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Life Time | Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time. | at replacement of voice prosthesis (maximum 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice Quality | Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20. | at 3 months or device change (whichever was first) | 
| Ease of Insertion | The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study. | assessed immediately after insertion procedure | 
| Reason for Replacement |  | At removal of prosthesis | 

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