Long Term Use of the Provox Vega 22.5
|ClinicalTrials.gov Identifier: NCT00884910|
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : November 3, 2010
Last Update Posted : July 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Total Laryngectomy||Device: Provox Vega voice prosthesis 22.5 Fr||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Device: Provox Vega voice prosthesis 22.5 Fr
- Patient Preference [ Time Frame: 3 months post insertion, or at end of device life (whichever comes sooner) ]Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".
- Device Life Time [ Time Frame: 6 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884910
|Netherlands Cancer Institute|
|Amsterdam, Noord Holland, Netherlands, 1066 CX|
|Principal Investigator:||Frans JM Hilgers, MD, PhD||The Netherlands Cancer Institute|