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

Atos Medical

Status: Terminated

Conditions: Total Laryngectomy

Treatments: Device: Provox Vega voice prosthesis (20 Fr)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00661570

UD736

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• current puncture problems (f. ex. infection)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Early feasability arm

Experimental group

Treatment:

Device: Provox Vega voice prosthesis (20 Fr)