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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40854

Enrollment

Registered

2014-04-29

Start date

2014-01-05

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngectomy removal of larynx

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Total laryngectomy 18 years or older HME user and/or handsfree speaking valve user Voice prosthesis user Longer than 3 months after total laryngectomy or postop radiotherapy

Exclusion criteria

Exclusion criteria: Patient is unable to remove or operate the device Active recurrent or metastatic disease (medical deterioration) Unable to complete patient diaries Unable to understand the Patient Information and/or unable to give Informed Consent

Design outcomes

Primary

Measure	Time frame
As this study is a clinical feasibility study, there are no specific outcomes for this study.	—

Secondary

Measure	Time frame
As this study is a clinical feasibility study, there are no specific outcomes for this study.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)