NCT00884910

Long Term Use of the Provox Vega 22.5

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Atos Medical AB · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Total Laryngectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-04-21
• Last updated: 2012-07-16
• Results posted: 2010-11-03

Locations

1 site across 1 country: Netherlands