Long Term Use of the Provox Vega 22.5

Study Overview
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Brief Summary
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The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.

Detailed Description
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Nowadays, many laryngectomized patients use a voice prosthesis to speak. The Provox2 is an indwelling voice prosthesis that has been on the market since 1997. Recently a new Provox voice prosthesis has been developed, the Provox Vega. This prosthesis is available in 3 different outer diameters. In this study the device with an outer diameter of 22.5 French is tested. The Provox Vega 22.5 is the successor of the Provox2 voice prosthesis. Both prostheses have an outer diameter of 22.5 French. Outcomes were recorded by means of patient questionnaires and device life. It is expected that some patients will like the new device (Provox Vega 22.5) better than the old one (Provox2) because the airflow resistance for speaking of the new prosthesis is lower when measured in a laboratory.

Official Title
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Amendment on Phase 1 Trial N07VEG Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega). Amendment 3: Long-term Use of the Provox Vega

Conditions
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Total Laryngectomy

Intervention / Treatment
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* Device: Provox Vega voice prosthesis 22.5 Fr


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: total laryngectomy Provox2 user at least two previous replacements Exclusion Criteria: patients' refusal fistula problems Provox ActiValve users
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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Provox Vega voice prosthesis 22.5 Fr|The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference | Patients were asked Which voice prosthesis do you prefer? Answer options were old one (Provox2), new one (Provox Vega 22.5), or no preference. | 3 months post insertion, or at end of device life (whichever comes sooner) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Life Time | Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngectomy, Provox Vega, voice prosthesis