Early clinical feasibility study of a new voice prosthesis: the Provox Vega HP
Completed
- Conditions
- 'total laryngectomy' 'voice rehabilitation'10019190
- Registration Number
- NL-OMON38672
- Lead Sponsor
- Atos Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Laryngectomized patients using either the Provox Vega or the Provox ActiValve Light voice prosthesis, with a length of 6, 8, or 10 mm
Age: 18 years or older
Exclusion Criteria
-Current tracheoesophageal puncture problems such as enlarged puncture or infection
-Active recurrent or metastatic disease (medical deterioration)
-Unable to understand the patient information and/or unable to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The design of the study is in line with the early nature of the investigation<br /><br>and is observational. There are no specific outcome measures or endpoints.<br /><br>The investigation will cover the advantages and limitations of the new valve<br /><br>flap design and material related to short-term aspects such as noise of VP,<br /><br>bloating issues, leakage, inadvertent opening of the valve (i.e. leakage), and<br /><br>stickiness of the valve, voice and speech quality, speaking effort, and<br /><br>possible effects on voice prosthesis cleaning procedures, frequency and<br /><br>effectiveness of cleaning.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>