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Long Term Use of the Provox Vega 22.5

NCT00884910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-07-16

Study results available
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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.

Conditions

  • Total Laryngectomy

Interventions

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.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Atos Medical AB

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-03-31
Completion
2010-03-31

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 NCT00884910 on ClinicalTrials.gov