Feasibility study of a mouldable peristomal adhesive for pulmonary and speech rehabilitation after total laryngectomy.

Phase 4

Completed

Conditions: removal of larynx
laryngectomy
10019190

Registration Number: NL-OMON48404

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Total laryngectomized patient
- 18 years or older
- Voice prosthesis users
- Regular hands-free speech users: ASV with integrated HME
- Peristomal adhesive users (StabiliBase, XtraBase, FlexiDerm)
- Longer than 3 months after total laryngectomy
- Longer than 6 weeks after postoperative radiotherapy

Exclusion Criteria

- LaryTube or LaryButton users
- Medical problems prohibiting the use of HME, ASV and/or adhesives
- Active recurrent or metastatic disease
- Reduced mobility of arms and/or hands
- Unable to understand patient information and/or to give informed consent
- Insufficient cognitive ability to handle the HME, ASV or mouldable adhesive

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to investigate the product performance<br /><br>of Provox Life FreeHands Adhesive in combination with hands-free speech, in<br /><br>subjects with a total laryngectomy, with the use of a study specific structured<br /><br>questionnaire. Product performance is defined as the individual fit,<br /><br>experienced comfort, user-friendliness, usability, and reasons for<br /><br>non-compliant use (device or non-device related). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to evaluate the device lifetime during hands-free<br /><br>speech and duration of hands-free speech compared to their standard peristomal<br /><br>adhesive (difference in [hours] or [hours/day], per subject) and the<br /><br>self-assessed subject satisfaction of Provox Life FreeHands Adhesive with the<br /><br>use of two study specific structured questionnaire.</p><br>