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

Total Laryngectomy Clinical Trial

Official title:
Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00661570
Study type Interventional
Source Atos Medical AB
Contact
Status Terminated
Phase Phase 2
Start date March 2008
Completion date March 2009
View Details
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