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临床试验/NCT01200199
NCT01200199已完成不适用

Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence

Boston Scientific Corporation0 个研究点目标入组 45 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
主要终点
To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins

研究概览

简要总结

The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Sign informed consent and complete study assessments in written English
  • •Male or female age 18 to 75
  • •Patients having Saphenofemoral Junction (SFJ) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg
  • •Screening Symptom score of 7 points or more as measured by Question 1 on the modified VEINES-QOL/Sym questionnaire

排除标准

  • •Unable to comply with completing a daily diary for a total of 24 days
  • •Participation in any other investigational pharmaceutical product, or device study within the 3 months prior to Visit 1
  • •Current venous leg ulcer in either leg

结局指标

主要结局

To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins

时间窗: 8 weeks

次要结局

  • To establish the treatment effect size of foam sclerotherapy treatment(8 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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