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OpenTrials
Completed

NCT Number: NCT00884910

Long Term Use of the Provox Vega 22.5

The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who currently use a Provox2 voice prothesis.

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Key information

Conditions

Total Laryngectomy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • total laryngectomy
  • Provox2 user
  • at least two previous replacements

Exclusion criteria

  • patients' refusal
  • fistula problems
  • Provox ActiValve users

Treatment and study plan

Provox Vega voice prosthesis 22.5 Fr

Device

The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.

Other names: indwelling voice prosthesis

Primary outcomes

  1. Patient Preference

    Time frame: 3 months post insertion, or at end of device life (whichever comes sooner)

    Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".

Secondary outcomes

  1. Device Life Time

    Time frame: 6 months

    Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • The Netherlands Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 21, 2009
Registry last updated
Jul 16, 2012

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.

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