Literature DB >> 19895334

Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega).

Frans J M Hilgers1, Annemieke H Ackerstaff, Maya van Rossum, Irene Jacobi, Alfons J M Balm, I Bing Tan, Michiel W M van den Brekel.   

Abstract

CONCLUSIONS: Provox Vega prostheses demonstrate good short-term feasibility, and their optimized airflow-resistance design offers laryngectomy patients indwelling voice prostheses with more choices in outer diameters without sacrificing (too) much in voice quality.
OBJECTIVES: Technological progress enables improvement of in vitro airflow characteristics of voice prostheses and design of voice prostheses with smaller outer diameters. This could potentially improve voice quality in users of Provox2, and avoid diminished voice quality in users of prostheses with smaller outer diameters.
METHODS: This was a prospective clinical phase I/feasibility study of three newly designed indwelling voice prostheses (Provox Vega 22.5 (Provox2 successor), 20, and 17Fr). Assessments consisted of patients' self-reported voice and speech, perceptual evaluation, acoustic analysis, maximum phonation time, loudness, speech rate, pull-out force and adaptation of the tracheoesophageal (TE) puncture to smaller diameter voice prostheses. Vega 22.5 was assessed in 15 patients (all Provox ActiValve users, observation period 3 weeks), and 16 patients with Vega 20/17 (2 weeks each).
RESULTS: No voice prostheses problems were encountered. Half of the patients with Vega 22.5 preferred that for its better voice quality. Voice and speech were considered equal to Provox2 for Vega 20, but slightly less for Vega 17. Most TE punctures adapted well to the smaller diameter voice prostheses.

Entities:  

Mesh:

Year:  2010        PMID: 19895334     DOI: 10.3109/00016480903283766

Source DB:  PubMed          Journal:  Acta Otolaryngol        ISSN: 0001-6489            Impact factor:   1.494


  6 in total

Review 1.  The development and treatment of periprosthetic leakage after prosthetic voice restoration. A literature review and personal experience part I: the development of periprosthetic leakage.

Authors:  Kai J Lorenz
Journal:  Eur Arch Otorhinolaryngol       Date:  2014-11-18       Impact factor: 2.503

2.  [Voice rehabilitation after laryngectomy. Initial clinical experience with the Provox-Vega® voice prosthesis and the SmartInserter® system].

Authors:  K J Lorenz; H Maier
Journal:  HNO       Date:  2010-12       Impact factor: 1.284

3.  [A novel puncture instrument: the Provox-Vega® puncture set. Its use in voice prosthesis insertion following laryngectomy].

Authors:  K J Lorenz; F M Hilgers; H Maier
Journal:  HNO       Date:  2013-01       Impact factor: 1.284

4.  Physiology and prospects of bimanual tracheoesophageal brass instrument play.

Authors:  F J M Hilgers; R Dirven; I Jacobi; M W M van den Brekel
Journal:  Acta Otorhinolaryngol Ital       Date:  2015-06       Impact factor: 2.124

5.  Development and (pre-) clinical assessment of a novel surgical tool for primary and secondary tracheoesophageal puncture with immediate voice prosthesis insertion, the Provox Vega Puncture Set.

Authors:  Frans J M Hilgers; Kai J Lorenz; Heinz Maier; Cees A Meeuwis; Jeroen D F Kerrebijn; Vincent Vander Poorten; Anne Sophie Vinck; Miquel Quer; Michiel W M van den Brekel
Journal:  Eur Arch Otorhinolaryngol       Date:  2012-03-06       Impact factor: 2.503

6.  Are modern voice prostheses better? A lifetime comparison of 749 voice prostheses.

Authors:  P Kress; P Schäfer; F P Schwerdtfeger; S Rösler
Journal:  Eur Arch Otorhinolaryngol       Date:  2013-06-29       Impact factor: 2.503

  6 in total

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