Clinical Feasibility of a new adhesive base plate (placeholder for stoma appliances) for rehabilitation after total laryngectomy

Phase 2

Completed

• Conditions: laryngectomy; removal of larynx; 10019190

• Registration Number: NL-OMON34698
• Lead Sponsor: Atos Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

laryngectomy
voice prosthesis user
HME user

Exclusion Criteria

skin problems tracheostoma, allergy to adhesive
medical problems prohibiting HME use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patient preference</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Device life of the adhesive<br /><br>Patient satisfaction<br /><br>Voice and Speech (perceptual evaluation, maximum phonation time, phrasing)<br /><br>Ease of application</p><br>