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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
33
The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
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".
Time frame: 3 months post insertion, or at end of device life (whichever comes sooner)
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.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.