NCT05494710Unknown不适用
Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment
研究概览
简要总结
The aim of the BEST study is to examine the feasibility of assessing patient and clinician reported outcome of a single electrosclerotherapy treatment of vascular malformations.
- Sclerotherapy = injection of Bleomycin into vascular birthmarks to seal off abnormal vascular channels
- Electroporation = application of an electric field to vessels treated with a handheld needle electrode
- Electrosclerotherapy = a combination of Bleomycin sclerotherapy and electroporation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •New patients presenting with a vascular malformation suitable for Bleomycin sclerotherapy treatment
- •Existing patients presenting with a poor response to treatment, performed more than 6 months ago
- •Placement of a needle electrode into the vascular malformation is technically possible
- •Evaluation of response to treatment is possible on photo documentation
- •Patients agreeing to participate in the study
- •The ability to understand written and spoken English
排除标准
- •Patients not agreeing to participate in the study
- •Pregnancy
- •Breastfeeding
- •Previous high systemic Bleomycin exposure (more than 3000 IU)
- •Patients unable to provide written, informed consent
- •Patients in which needle electrode placement is not possible
- •Response to treatment not evaluable by photo documentation
- •Patients unable to speak English
结局指标
主要结局
Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment
时间窗: 8 weeks
Patient reported quality of life after a single electrosclerotherapy treatment of vascular malformations - change in scores measured using Birthmark Quality of Life questionnaire (8 items measured on 5 point scale)
Clinician assessment tool of treatment response
时间窗: 8 weeks
Clinician assessment of treatment response following electrosclerotherapy treatment using clinical assessment tool - change in scores measured
次要结局
- To collect documented side effects following electrosclerotherapy treatment.(2 years)
研究者
研究点 (2)
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