A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses

Primary Objective:

To determine whether routine use of Provox® ActiValve® voice prosthesis decreases annual number of clinical procedures to exchange VP in indwelling voice prosthesis users after total laryngectomy with TEP.

Secondary Objectives:

• To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator)
• To compare outcomes, adverse events, and costs associated with prophylactic exchange of Provox® ActiValve® versus routine use of Provox® ActiValve® (experimental) or standard indwelling voice prostheses (comparator)

Exploratory objectives:

• To explore relationships between clinicodemographic features and device/TEP function
• To explore relationships between pharyngoesophageal pressures via manometry and device/TEP function
• To explore relationships between oral/tracheal microbiome and device/TEP function
• To describe novel use of prophylactic exchange of Provox® ActiValve®

Inclusion criteria

• Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture
• Using or ready for fit of indwelling voice prosthesis
• No evidence of disease (NED) in head and neck
• At least 6 months since cancer treatment
• TEP tract length 4.5 to 12.5mm at time of enrollment*

• The range reflects the available device sizes for the Provox® ActiValve® . Eligibility is determined by confirming that the patient is appropriately fitted with a VP within this size range, based on the site's standard clinical practice (e.g. appearance/fit and/or depth gauge).

Exclusion criteria

• History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months)
• History of recurrent VP extrusion (within last 12 months)
• Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU)
• History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months)
• Active malignancy in head and neck and/or chest at the time of enrollment
• Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment
• Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons
• Planned regular VP exchanges at outside facility within next 12 months
• History of gastric pull-up reconstruction