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To determine the effect and safety of Varisolve® 0.125% [0.2%]
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varisolve 0.125% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polidocanol Endovenous Microfoam 0.125% | Drug | Polidocanol Endovenous Microfoam 0.125%, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Evans | BTG International Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue | Washington | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polidocanol Injectable Foam 0.125% | polidocanol injectable foam 0.125%, single dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Treated With Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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all patients treated with polidocanol injectable foam 0.125%
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| ID | Title | Description |
|---|---|---|
| BG000 | Polidocanol Injectable Foam 0.125% | polidocanol injectable foam 0.125%, single dose |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polidocanol Injectable Foam 0.125% | polidocanol injectable foam 0.125%, single dose | 0 | 16 | 9 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| extravasation | General disorders | Systematic Assessment |
| ||
| local swelling | General disorders | Systematic Assessment |
| ||
| limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Wright MB FRCS | BTG International Inc | 610-943-3513 | david.wright@btgplc.com |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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