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

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

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.

Inclusion Criteria:

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

Exclusion Criteria:

• current puncture problems (f. ex. infection)