Multi-centre, Open-label, First-in-man Study With Mucopad HA Used in Adult Patients Suffered From Oral Mucositis After Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Resolution of mucositis symptoms since completion of radiotherapy
研究概览
简要总结
The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results.
详细描述
This is an multi-centre, open-label, first-in-man prospective study.
Up to 60 patients in total will be involved in the open-label trial of new medical device - Mucopad HA. Eligible patients will be undergoing treatment with the device for up to 10 weeks, after which it is expected that there should be significant improvement in the healing process of oral mucositis after radiotherapy. It is considered as an improvement when there is a significant reduction or complete resolution of the mucositis. Mucositis will be assessed as a WHO scale.
Quality of life will be assessed by Oral Mucositis Daily Questionnaire (OMDQ) provided by FACIT. The FACIT and all related works are owned and copyrighted by, and the intellectual property of David Cella, Ph.D. Permission for use of the OMDQ questionnaire is obtained by contacting Dr. Cella at information@facit.org.
List of investigational sites is in appendix 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Oral Mucositis after radiotherapy of grade I - IV according to WHO
- •Patient willing and able to provide the written consent
- •Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study
排除标准
- •Age < 18 years
- •Pregnant or lactating women
- •Patients in terminal stage of living
- •Patients with known hypersensitivity or allergy to any of the substances contained in Medical Device
- •Alcohol or drug abuse
结局指标
主要结局
Resolution of mucositis symptoms since completion of radiotherapy
时间窗: 10 weeks
healing time
次要结局
- Development of xerostomy(10 weeks)
- - Pain management (VAS scale)(10 weeks)
- Subjective evaluation on scale 1-5 of the treatment by investigator/ patient(10 weeks)