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

Completed

• Conditions: Patienten na laryngectomie met stemprothese; Larynx extirpation; removal of the larynx

• Registration Number: NL-OMON50825
• Lead Sponsor: Atos Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The research concerns the advantages and limitations of the new valve design<br /><br>and material with respect to short term aspects such as valve stickiness, voice<br /><br>quality and difficulty speaking.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Stickiness of the valve, speaking effort, voice quality.</p><br>