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Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis

NCT00743262 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-07-25

Study results available
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Summary

The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients. Factors taken into account are clinician and patient satisfaction with the insertion system, patient satisfaction with voice, speech, performance, and maintenance. Voice and speech will also be evaluated for the different prostheses by means of perceptual evaluations and acoustic analysis.

Conditions

  • Total Laryngectomy

Interventions

DEVICE

Provox voice prosthesis

The current voice prosthesis (Provox ActiValve)of the patients will be removed and a new prosthesis (Provox Vega) 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

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-08-31
Completion
2009-04-30

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 NCT00743262 on ClinicalTrials.gov