Clinical assessment of a new adhesive and HME for night-time use in laryngectomized patients: Provox Luna
Phase 4
Withdrawn
- Conditions
- Laryngectomyremoval of larynx10019190
- Registration Number
- NL-OMON43035
- Lead Sponsor
- Atos Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
Total laryngectomy
18 years or older
HME user
Longer than 3 months after total laryngectomy or postop radiotherapy
Exclusion Criteria
Medical problems prohibiting the use of HME or adhesive
Active recurrent or metastatic disease (medical deterioration)
Reduced mobility of arms and/or hands, unable to remove an HME
Unable to understand the Patient Information and/or unable to give Informed Consent
Insufficient cognitive ability to handle the HME or adhesive
Use of LaryTube during night on medical prescription (e.g. shrinking stoma)
Too low tidal volume as this may cause carbon dioxide retention
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is compliant use of the HME.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome measures for the Provox Luna Adhesive are performance<br /><br>(stickiness, comfort, cooling and soothing of the skin, visibility of the skin)<br /><br>and skin effects (healing/recovering of skin, severity and frequency of skin<br /><br>irritation and pain reduction). The secondary outcome measures of the Provox<br /><br>Luna HME are performance (breathing, speaking, comfort of the device),<br /><br>pulmonary effects (coughing, forced expectorations, tracheal irritation, mucus<br /><br>production) and Quality of Life (sleeping, EQ-5D).<br /><br>Overall satisfaction with Provox Luna (both the adhesive and the HME) is also a<br /><br>secondary outcome measure.</p><br>