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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".
3 months post insertion, or at end of device life (whichever comes sooner)
Frans JM Hilgers, MD, PhD
The Netherlands Cancer Institute
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
N07VEGA Amendment 22.5