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

Is the Provox ActiValve Only a Problem Solver? A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses After Total Laryngectomy With Tracheoesophageal Puncture

The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually.

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:

1. To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator)
2. 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:

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

Inclusion Criteria:

1. Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture

2. Using or ready for fit of indwelling voice prosthesis

3. No evidence of disease (NED) in head and neck

4. At least 6 months since cancer treatment

5. 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:

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