Varicose VeinsPhase 2NCT00928421
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
A Phase 2 study testing Polidocanol Endovenous Microfoam 0.125% in people with Varicose Veins, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
To determine the effect and safety of Varisolve® 0.125% [0.2%] Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Polidocanol Endovenous Microfoam 0.125%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male or female; age of consent to 75 years
- Baseline VEINES-Sym Questionnaire score less than 75 points
- Superficial venous disease manifested by both symptoms and visible varicosities
- Varicose vein clinical classification CEAP 2 through 5
- Incompetence of SFJ (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
- Ability to comprehend and sign an informed consent document and complete study questionnaires in English
Who cannot join
- Incompetence of the small saphenous vein (SSV)
- Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
- Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
- Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
- Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
- Planned prolonged automobile, bus, or air travel within 4 weeks following treatment, unless the patient can walk for at least 5 consecutive minutes every hour during travel.
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- History of pulmonary embolism or stroke.
- Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
- Current anticoagulation therapy (within 7 days of enrollment).
- Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening.
- Previous treatment in this study or in a previous Varisolve® study.
- Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) or clinically significant laboratory abnormalities.
- Known allergic response to polidocanol, or severe and multiple allergic reactions.
- Women of childbearing potential not using effective contraception for at least one month prior to study enrollment and/or unwilling to continue birth control until their last study visit.
- Pregnant or lactating women.
- Current alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose Pilot Study to Evaluate the Efficacy and Safety of Varisolve® (Polidocanol Endovenous Microfoam) 0.125% [0.2%] for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence
To determine the effect and safety of Varisolve® 0.125% [0.2%]
Read the detailed description
In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% [0.2%] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein
- Conditions
- Varicose Veins
- Being tested
- Polidocanol Endovenous Microfoam 0.125%
- Keywords
- 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.
Polidocanol Endovenous Microfoam 0.125%Drug
Also called Varisolve 0.125%
Polidocanol Endovenous Microfoam 0.125%, single dose
| Study group | Role | What they receive |
|---|---|---|
| Varisolve 0.125% | Experimental | Not described Receives: Drug: Polidocanol Endovenous Microfoam 0.125% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders to Treatment, Assessed by Duplex Ultrasound
Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.
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 posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ellen Evans, Study chair, BTG International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928421
- Sponsor's protocol ID
- VAP.VV014
- Status last verified
- Apr 2021
- First submitted
- 24 Jun 2009
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Pilot Study to Evaluate the Efficacy and Safety of Varisolve® (Polidocanol Endovenous Microfoam) 0.125% [0.2%] for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence
- ClinicalTrials.gov ID
- NCT00928421
- Acronym / sponsor ID
- VAP.VV014
- Conditions
- Varicose Veins
- Keywords
- Varicose Veins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect and safety of Varisolve® 0.125% [0.2%]
Detailed description
In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% [0.2%] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varisolve 0.125% | Experimental | Drug: Polidocanol Endovenous Microfoam 0.125% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female; age of consent to 75 years
- Baseline VEINES-Sym Questionnaire score less than 75 points
- Superficial venous disease manifested by both symptoms and visible varicosities
- Varicose vein clinical classification CEAP 2 through 5
- Incompetence of SFJ (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
Key exclusion criteria (16 listed)
- Incompetence of the small saphenous vein (SSV)
- Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
- Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
- Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
- Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polidocanol Endovenous Microfoam 0.125%Also: Varisolve 0.125%Polidocanol Endovenous Microfoam 0.125%, single dose | Drug | Varisolve 0.125% |
Primary outcome
Responders to Treatment, Assessed by Duplex Ultrasound
Time frame: 8 weeks
Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ellen Evans study chair
BTG International Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polidocanol Endovenous Microfoam 0.125% in people with Varicose Veins, run by Boston Scientific Corporation at 1 site in United States.
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 6 inclusion and 16 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 13 May 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 States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Responders to Treatment, Assessed by Duplex Ultrasound (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 13 May 2021; AzTrials last refreshed its copy on 27 Oct 2026.