Validity of Electronic Diary for Monitoring Varicose Veins Symptoms

NCT ID: NCT01200199

Last Updated: 2021-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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Conditions

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Varicose Veins

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Varicose veins

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Wright, MD

Role: STUDY_DIRECTOR

BTG International Inc.

Locations

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Birmingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RS-002

Identifier Type: -

Identifier Source: org_study_id

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