Varicose VeinsNCT01200199
Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
An observational study of Varicose Veins, run by Boston Scientific Corporation at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Varicose Veins
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Varicose veins
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence
The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.
- Conditions
- Varicose Veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Varicose veins | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
To establish the treatment effect size of foam sclerotherapy treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wright, MD, Study director, BTG International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200199
- Sponsor's protocol ID
- RS-002
- Status last verified
- Apr 2021
- First submitted
- 8 Sep 2010
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence
- ClinicalTrials.gov ID
- NCT01200199
- Acronym / sponsor ID
- RS-002
- Conditions
- Varicose Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varicose veins | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Varicose veins
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To establish the treatment effect size of foam sclerotherapy treatment
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wright, MD study director
BTG International Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by Boston Scientific Corporation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.