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NCT01200199 Clinical Trial

Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

Varicose Veins Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01200199
Other study ID # RS-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2010
Est. completion date August 2011

Study information
Verified date April 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 8 weeks
Secondary To establish the treatment effect size of foam sclerotherapy treatment 8 weeks
See also
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Completed NCT01231373 - Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence Phase 3