Long Term Use of the Provox Vega 22.5

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Total Laryngectomy

Clinical Trial Details

NCT number	NCT00884910
Study type	Interventional
Source	Atos Medical AB
Contact
Status	Completed
Phase	Phase 2
Start date	February 2008
Completion date	March 2010

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