Skip to main content
OpenTrials
Completed

NCT Number: NCT00743262

Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Laryngectomy Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Total laryngectomy
  • Use Provox ActiValve

Exclusion criteria

  • Current problems with TE puncture

Treatment and study plan

Provox voice prosthesis

Device

The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) will be inserted

Other names: Indwelling voice prosthesis

Primary outcomes

  1. Short-term Feasibility Provox Vega 22.5 French

    Time frame: 3 weeks

    Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.

Secondary outcomes

  1. Subjective Voice and Speech Quality

    Time frame: 3 weeks

    Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.

  2. Device Life Time

    Time frame: one year

    Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • The Netherlands Cancer Institute

Registry information

Official study title

Second Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)': Vega Siri Addendum.

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 28, 2008
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.