CTRI/2021/08/036007尚未招募4 期
Prospective, Multicenter, single arm, non-comparative study, to assess the speech quality of alaryngeal voice in patients using AUM voice prosthesis.
Social Alpha0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1. Life expectancy >=10 months.
- •2. Surgically and medically fit for undergoing a total laryngectomy ± partial phrenectomy, or had already undergone total laryngectomy ± partial phrenectomy >=6weeks prior and were willing for a secondary voice rehabilitation procedure.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (ECOG) <=2.
- •4. Available for follow-up for the duration of the study.
排除标准
- •1. Known allergy or expected hypersensitivity in the opinion of the investigator.
- •2. Patients with partial laryngectomy, near-total laryngectomy, utilizing alternative ways of post-laryngectomy voice rehabilitation (for secondary insertion).
- •3. Patients with total laryngo-pharyngectomy with gastric pull up not permitting insertion of Tracheoesophageal prosthesis (TEP)
- •4. Aphonia
- •5. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- •6. Any specific condition that in the judgment of the investigator precludes participation because it could affect Patient safety.
- •7. Pregnant women or lactating Mother
研究者
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