An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
Primary Purpose
Varicose Veins
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Polidocanol Endovenous Microfoam 0.125%
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring Varicose Veins
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Varisolve 0.125%
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00928421
First Posted
June 24, 2009
Last Updated
April 19, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00928421
Brief Title
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Varicose Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varisolve 0.125%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Polidocanol Endovenous Microfoam 0.125%
Other Intervention Name(s)
Varisolve 0.125%
Intervention Description
Polidocanol Endovenous Microfoam 0.125%, single dose
Primary Outcome Measure Information:
Title
Responders to Treatment, Assessed by Duplex Ultrasound
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Evans
Organizational Affiliation
BTG International Inc.
Official's Role
Study Chair
Facility Information:
City
Bellevue
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
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