跳至主要内容
临床试验/NL-OMON43035
NL-OMON43035撤回4 期

Clinical assessment of a new adhesive and HME for night-time use in laryngectomized patients: Provox Luna - Clinical assessment of the Provox Luna

Atos Medical AB0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
入组人数
45

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Total laryngectomy
  • 18 years or older
  • Longer than 3 months after total laryngectomy or postop radiotherapy

排除标准

  • 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

研究者

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