Long Term Use of the Provox Vega 22.5

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884910
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : November 3, 2010
Last Update Posted : July 16, 2012
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Atos Medical AB

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Total Laryngectomy Device: Provox Vega voice prosthesis 22.5 Fr Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Study Start Date : February 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Intervention Details:
  • Device: Provox Vega voice prosthesis 22.5 Fr
    The patients' current Provox2 voice prosthesis will be removed and the new Provox Vega voice prosthesis will be inserted.
    Other Name: indwelling voice prosthesis

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • patients' refusal
  • fistula problems
  • Provox ActiValve users

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884910

Netherlands Cancer Institute
Amsterdam, Noord Holland, Netherlands, 1066 CX
Sponsors and Collaborators
Atos Medical AB
The Netherlands Cancer Institute
Principal Investigator: Frans JM Hilgers, MD, PhD The Netherlands Cancer Institute

Responsible Party: Atos Medical AB Identifier: NCT00884910     History of Changes
Other Study ID Numbers: N07VEGA Amendment 22.5
First Posted: April 21, 2009    Key Record Dates
Results First Posted: November 3, 2010
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by Atos Medical AB:
Provox Vega
voice prosthesis