Long Term Use of the Provox Vega 22.5

Atos Medical

Status and phase

Completed

Phase 2

Conditions

Total Laryngectomy

Treatments

Device: Provox Vega voice prosthesis 22.5 Fr

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00884910

N07VEGA Amendment 22.5

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria