Long Term Use of the Provox Vega 22.5

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

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.

Study Overview

• Status: Completed
• Conditions: Total Laryngectomy
• Intervention / Treatment: Device: Provox Vega voice prosthesis 22.5 Fr

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
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1066 CX
      • Netherlands Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients' refusal
• fistula problems
• Provox ActiValve users

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Preference	Patients were asked "Which voice prosthesis do you prefer?" Answer options were "old one (Provox2)", "new one (Provox Vega 22.5)", or "no preference".	3 months post insertion, or at end of device life (whichever comes sooner)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Life Time	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.	6 months

Collaborators and Investigators

• Sponsor: Atos Medical AB
• Collaborators: The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 20, 2009
• First Submitted That Met QC Criteria: April 20, 2009
• First Posted (Estimate): April 21, 2009

Study Record Updates

• Last Update Posted (Estimate): July 16, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: laryngectomy; Provox Vega; voice prosthesis
• Other Study ID Numbers: N07VEGA Amendment 22.5