Clinical assessment of a new speaking valve for hands-free speech in laryngectomized patients: Provox® FreeHands FlexiVoice

Since the first handsfree speaking valves for laryngectomees were introduced to
the market in the early eighties, several devices with incremental changes have
been developed. The Provox FreeHands HME that was introduced in 2003 was the
first handsfree speaking valve with an integrated HME for pulmonary
rehabilitation. The main drawback of all handsfree speaking valves is that it
can be problematic to get a good seal of the adhesive to withstand the pressure
generated during speaking. In this study a newly developed handsfree speaking
valve will be tested. The new speaking valve can be used for hands free speech
and can also be occluded manually. The speaking valve has been developed with
the aim to increase the proportion of subjects able to successfully use a
handsfree speaking valve.

The objective of this clinical investigation is to evaluate the short- and
long-term clinical feasibility of the Provox FreeHands FlexiVoice, in
combination with the currently available attachments, and explore its
limitations and advantages.

This study will be a non-randomized prospective multi-center study in 40
laryngectomized subjects. Clinical feasibility of the Provox Freehands
FlexiVoice will be investigated with a focus on both short- and long-term
performance and compliance. The outcomes will be recorded by means of
structured and comparative questionnaires, voice assessment, VAS scales, EQ-5D,
and subject diaries.

Subjects will first use the Provox FreeHands FlexiVoice for a period of two
weeks in order to get used to the device. After that, the patient will be
phoned for follow-up and will be offered support from either the speech
pathologist or the investigator, if needed. Then, the subject will visit the
hospital after one month for voice assessment and questionnaires. A short
follow-up is done per phone at month 2, 3, 4 and 5. At month 6, the end of the
study, the subject can either come back to the hospital or complete the final
questionnaires by phone.

No new risks have been identified related to the Provox FreeHands FlexiVoice.
It is expected that the study may be of some burden to some subjects due to the
fact that the subjects are required to keep a diary of their experiences with
the attachment methods and the use of the Provox FreeHands FlexiVoice. And it
could also be a burden for them if the automatic speaking valve that they are
asked to try out does not work well for them. Also the visits to the hospital
can be experienced as burdensome. Visit 1 and 2 are expected to take 45
minutes. The last visit/phone call will likely be shorter in duration. The
follow-ups by phone will all be short.