This study was conducted (in part) under an unrestricted research grant of Atos Medical AB, Hörby, Sweden, which also provided the devices for this study. The authors have no other funding, financial relationships, or conflicts of interest to disclose.
Head and Neck
Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox Smart Inserter)†
Article first published online: 12 MAY 2010
Copyright © 2010 The American Laryngological, Rhinological, and Otological Society, Inc.
Volume 120, Issue 6, pages 1135–1143, June 2010
How to Cite
Hilgers, F. J. M., Ackerstaff, A. H., Jacobi, I., Balm, A. J. M., Tan, I. B. and van den Brekel, M. W. M. (2010), Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox Smart Inserter). The Laryngoscope, 120: 1135–1143. doi: 10.1002/lary.20925
- Issue published online: 21 MAY 2010
- Article first published online: 12 MAY 2010
- Manuscript Accepted: 4 MAR 2010
- Manuscript Revised: 1 MAR 2010
- Manuscript Received: 17 JAN 2010
- Atos Medical AB, Hörby, Sweden
- Total laryngectomy;
- voice rehabilitation;
- indwelling voice prosthesis;
- prosthesis replacement;
- Level of Evidence: 1b.
To assess device life of the new Provox Vega 22.5 and 20 Fr prostheses, to establish whether the optimized airflow characteristics of these devices materialize in better voice characteristics in comparison to Provox2, and to assess the feasibility of voice prosthesis replacement with the new Smart Inserter.
Prospective clinical phase II study.
Prospective clinical phase II study including two patient cohorts (Provox Vega 22.5 Fr: N = 33; Provox Vega 20 Fr: N = 26). Device-life assessment, subjective data collection with study-specific structured questionnaires, perceptual analysis (Comparative Mean Opinion Score), and objective voice analysis (standard Dutch text, maximum phonation time, and dynamic range).
Device life of both prostheses appears comparable to Provox2. Several voice characteristics were better in Vega 22.5, which coincides well with patients' preference. Voicing with Vega 20 appears comparable to Provox2. Use of Smart Inserter showed a short learning curve, and was considered an improvement by the clinicians.
The new Provox Vega 22.5 and 20 Fr prostheses have a device life comparable to Provox2, whereas voicing is better than (with the 22.5Fr version) or comparable (with the 20 Fr version) to Provox2. The Smart Inserter, after a short learning curve, turns out to be a further improvement of the anterograde replacement of these indwelling devices.