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

NCT ID: NCT00661570

Last Updated: 2017-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Laryngectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early feasability arm

Group Type EXPERIMENTAL

Provox Vega voice prosthesis (20 Fr)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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indwelling Provox voice prosthesis

Eligibility Criteria

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Inclusion Criteria

* total laryngectomy
* use Provox2 voice prosthesis
* at least two prior prosthesis changes

Exclusion Criteria

* current puncture problems (f. ex. infection)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Atos Medical AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frans JM Hilgers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Michiel WM van den Brekel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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UD736

Identifier Type: -

Identifier Source: org_study_id

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