Clinical Feasibility of a New Voice Prosthesis

Early Clinical Feasibility Study of a New Voice Prosthesis

The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.

Inclusion Criteria:

• Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
• 18 years and older

Exclusion Criteria:

• Current tracheoesophageal puncture problems such as enlarged puncture or infection
• Active recurrent or metastatic disease (medical deterioration)
• The use of ActiValve Strong/XtraStrong or XtraSeal
• Unable to understand the Patient Information and/or unable to give Informed Consent
• The previous 2 VPs had a device lifetime > 12 months
• History of oral resections negatively affecting speech