title: Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega).
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, Amsterdam, The Netherlands. f.hilgers@nki.nl
authors.forename: Frans J M
authors.initials: FJ
authors.lastname: Hilgers
authors.forename: Annemieke H
authors.initials: AH
authors.lastname: Ackerstaff
authors.forename: Maya
authors.initials: M
authors.lastname: van Rossum
authors.forename: Irene
authors.initials: I
authors.lastname: Jacobi
authors.forename: Alfons J M
authors.initials: AJ
authors.lastname: Balm
authors.forename: I Bing
authors.initials: IB
authors.lastname: Tan
authors.forename: Michiel W M
authors.initials: MW
authors.lastname: van den Brekel
mesh_terms: D000368:Aged; D000403:Airway Resistance; D055154:Dysphonia / Q000175:diagnosis; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007825:Laryngectomy; D007831:Larynx, Artificial; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D014833:Voice Quality