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Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovenous ablation+polidocanol injectable microfoam 0.125% | Experimental | Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein |
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| Endovenous ablation+polidocanol injectable micrfoam, 1.0% | Experimental | Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein |
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| endovenous ablation+vehicle (placebo) | Active Comparator | endovenous ablation followed by injection of vehicle (placebo) to target vein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovenous ablation+polidocanol injectable microfoam 0.125% | Drug | All components except API |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins. | IPR-V3 measured at baseline and then at 8 weeks |
| Absolute Change From Baseline in PA-V3 Score | The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4) | PA-V3 measured at baseline and then at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85255 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26957489 | Derived | Vasquez M, Gasparis AP; Varithena(R) 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017 May;32(4):272-281. doi: 10.1177/0268355516637300. Epub 2016 Mar 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endovenous Ablation, Vehicle Placebo | Endovenous ablation followed by vehicle placebo |
| FG001 | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | Endovenous ablation followed by polidocanol injectable foam, 0.5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Endovenous ablation+polidocanol injectable microfoam 1.0% | Drug | endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0% |
|
|
| Endovenous ablation+polidocanol injectable foam 2.0% | Drug | Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0% |
|
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| Bradenton |
| Florida |
| 34209 |
| United States |
| Oak Brook | Illinois | 60523 | United States |
| North Tonawanda | New York | 14120 | United States |
| Stony Brook | New York | 11974 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Kirkland | Washington | 98034 | United States |
| FG002 | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | endovenous ablation followed by polidocanol injectable foam 1.0% |
| COMPLETED |
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| NOT COMPLETED |
|
all treated patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Endovenous Ablation, Vehicle Placebo | Endovenous ablation followed by vehicle placebo |
| BG001 | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | Endovenous ablation followed by polidocanol injectable foam, 0.5% |
| BG002 | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | endovenous ablation followed by polidocanol injectable foam 1.0% |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg^m2 |
|
| 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 | Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins. | Posted | Least Squares Mean | Standard Error | score | IPR-V3 measured at baseline and then at 8 weeks |
|
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| Primary | Absolute Change From Baseline in PA-V3 Score | The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4) | Posted | Least Squares Mean | Standard Error | score | PA-V3 measured at baseline and then at 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 | Endovenous Ablation, Vehicle Placebo | Endovenous ablation followed by vehicle placebo | 0 | 38 | 20 | 38 | ||
| EG001 | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | Endovenous ablation followed by polidocanol injectable foam, 0.5% | 0 | 39 | 29 | 39 | ||
| EG002 | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | endovenous ablation followed by polidocanol injectable foam 1.0% | 0 | 40 | 35 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| extravasation | General disorders | Systematic Assessment |
| ||
| infusion site thrombosis | General disorders | Systematic Assessment |
| ||
| edema peripheral | General disorders | Systematic Assessment |
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| tenderness | General disorders | Systematic Assessment |
| ||
| upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pain in extermity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
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| hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| thrombophlebitis superficial | Vascular disorders | Systematic Assessment |
| ||
| thrombosis | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Wright MB FRCS | BTG International Inc | 610-278-1660 | david.wright@btgplc.com |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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