The objectiveof this study is to evaluate the short term clinical applicability of the Provox Vega HP and to investigate its potential limitations and benefits. As a result of the evaluations, the design could be adapted to arrive at the optimal…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patienten na laryngectomie met stemprothese
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The research concerns the advantages and limitations of the new valve design
and material with respect to short term aspects such as valve stickiness, voice
quality and difficulty speaking.
Secondary outcome
Stickiness of the valve, speaking effort, voice quality.
Background summary
Feasibility of the novel voice prosthesis Provox Vega HP.
Study objective
The objectiveof this study is to evaluate the short term clinical applicability
of the Provox Vega HP and to investigate its potential limitations and
benefits. As a result of the evaluations, the design could be adapted to arrive
at the optimal design. The main result is the acceptance of the Provox Vega HP
and the patient's preference. Secondary outcomes are stickiness of the voice
prosthesis and speech.
Study design
This is a prospective feasibility study in which 15-20 patients will be
recruited. Patients will use the Provox Vega HP for two weeks to evaluate
short-term feasibility and explore limitations and benefits. Voice recordings
are made twice, with the current voice prosthesis and with the Provox Vega HP.
Participants complete questionnaires twice; Before the study and after wearing
the Provox Vega HP for 2 weeks.
If the participant wishes to leave the Provox Vega HP in situ after the 2 study
weeks, this is allowed on the condition that the subject agrees to remain in
the study and to report (adverse) events continuously, until the voice
prosthesis is removed after a maximum of 12 months.
Study burden and risks
There are no risks associated with the research. The voice prosthesis change
can be experienced as a burden. Daily care of the voice prosthesis with
lubricant can be experienced as a burden.
Kraftgatan 8
Horby 242 35
SE
Kraftgatan 8
Horby 242 35
SE
Listed location countries
Age
Inclusion criteria
• Laryngectomized patients using either the Provox Vega 22.5 or the Provox
ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
• 18 years and older
Exclusion criteria
• Current tracheoesophageal puncture problems such as enlarged puncture or
infection
• Active recurrent or metastatic disease (medical deterioration)
• The use of ActiValve Strong/XtraStrong or XtraSeal
• Unable to understand the Patient Information and/or unable to give Informed
Consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76694.031.21 |