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Clinical Trials/NCT01200199
NCT01200199
Completed
Not Applicable

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

Boston Scientific Corporation0 sites45 target enrollmentNovember 2010
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ConditionsVaricose Veins

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Varicose Veins
Sponsor
Boston Scientific Corporation
Enrollment
45
Primary Endpoint
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
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
August 2011
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

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

Time Frame: 8 weeks

Secondary Outcomes

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

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