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Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis

NCT00661570 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-03-10

Study results available
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Summary

The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.

Conditions

  • Total Laryngectomy

Interventions

DEVICE

Provox Vega voice prosthesis (20 Fr)

The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Atos Medical AB

    lead INDUSTRY

Principal Investigators

  • Frans JM Hilgers, MD, PhD · The Netherlands Cancer Institute

  • Michiel WM van den Brekel, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661570 on ClinicalTrials.gov