Early clinical feasibility study of a new voice prosthesis: the Provox Vega HP

Since voice prostheses were introduced on the market in the eighties, several
changes of the devices have taken place. Some of the incremental changes were
to further improve the device, but new types of devices were also developed for
specific populations, such as the Provox ActiValve. In this study, a newly
developed voice prosthesis will be tested: the Provox Vega HP. The prosthesis
has been developed with the aim of increasing device life. Before conducting a
long-term study investigating device life, the limitations and advantages of
the Provox Vega HP need to be explored in this early clinical feasibility
study.

The objective of this clinical investigation is to evaluate the short-term
clinical feasibility of Vega HP and explore its 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.

Prospective Phase I feasibility study in which 8 current Provox Vega users and
8 current Provox ActiValve Light users will be recruited for the study.
Patients will use the Provox Vega HP for two weeks to investigate short term
feasibility and explore limitations and advantages. If the patient does not
experience any problems and wishes to leave the Provox Vega HP in situ, this
will be allowed under the condition that the subject agrees to remain in the
study and report adverse events on an ongoing basis, until the device is
removed after a maximum of 6 months.

Use of the Provox Vega HP for the duration of two weeks with the option of
leaving the device in situ until replaced for device failure or other reason,
with a maximum of 6 months.

Since all subjects are current voice prosthesis users, no additional or other
risks are expected when using the Provox Vega HP instead of the Provox Vega or
Provox ActiValve Light.
The patient may consider the replacement of the prosthesis as a burden.
However, patients require regular replacements and are therefore accustomed to
the procedure. Depending on the performance of the new Provox Vega HP, it is
possible that the Provox Vega users may experience stickiness of the valve flap
leading to blockage and higher speaking effort as a burden, and that Provox
ActiValve users may experience inadvertent valve opening during swallowing
and/or inhalation possibly leading to intermittent leakage or gastric
filling/bloating as a burden. Also the outpatient clinic visits and completion
of the questionnaires at baseline and after two weeks, and the follow-up by
phone during long term use of the Vega HP may be considered a burden.