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The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.
A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varithena®, then Radiofrequency Ablation | Experimental | Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used. This was followed by RFA treatment. |
|
| Radiofrequency ablation then Varithena | Active Comparator | RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. This was followed by treatment with Varithena. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varithena® | Drug | Varithena® treatment in accordance with full prescribing information and instructions for use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine. | 14 day average (0-100) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Pain | degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine | immediately following procedure |
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Inclusion Criteria:
Exclusion Criteria:
Prior GSV treatment in either leg
Non-venous source of pain in either leg that could confound the results of the study
Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study
History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound
Deep venous reflux unless clinically insignificant in comparison to superficial reflux
Inability to wear post-procedure compression bandaging and stockings
Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
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.)
Contraindications to Varithena® (e.g., acute thromboembolic disease) or RFA according to the manufacturer's prescribing information
Known allergic response to polidocanol and/or multiple allergic reactions
Current or history of alcohol or drug abuse
Pregnant or lactating women
Women of childbearing potential not using effective contraception for at least one month prior to study treatment and/or unwilling to continue birth control for the duration of the study
Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening
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| Name | Affiliation | Role |
|---|---|---|
| David Wright, MD | BTG International Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Vascular and Interventional, PLLC | Pensacola | Florida | 32503 | United States | ||
| Midwest Institute for Minimally Invasive Therapies |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varithena® First Then Radiofrequency Ablation | Patients receive Varithena® treatment first in one leg, with 4-week follow-up period in Part 1; followed by Radiofrequency ablation in the other leg in Part 2. Varithena® treatment administered in accordance with full prescribing information and instructions for use. Radiofrequency ablation conducted per physicians' standard of care |
| FG001 | Radiofrequency Ablation First Than Varithena | Patients will receive radiofrequency ablation treatment first in one leg, with 4-week follow-up period in Part 1; followed by Varithena® in the other leg in Part 2. Varithena® treatment administered in accordance with full prescribing information and instructions for use. Radiofrequency ablation conducted per physicians' standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
| |||||||||||||
| Part 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varithena® | Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use followed by Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care. Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care followed by Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain | 14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine. | Posted | Mean | Standard Error | units on a scale | 14 day average (0-100) |
|
A period of time ending at Week 4 (day 32)
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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 | Varithena® | Varithena® treatment in accordance with full prescribing information and instructions for use Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Allen | BTG International Inc. | 425-410-3152 | lynn.allen@btgplc.com |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077423 | Polidocanol |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
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|
| Radiofrequency ablation | Device | Radiofrequency ablation conducted per physicians' standard of care. |
|
|
| Patient Preference |
Patient preference for RFA or Varithena® using e-diary |
| 8 weeks |
| Melrose Park |
| Illinois |
| 60160 |
| United States |
| Venous Institute of Buffalo | Amherst | New York | 14226 | United States |
| Lake Washington Vascular | Bellevue | Washington | 98004 | United States |
| NOT COMPLETED |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Radiofrequency Ablation | RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care. |
|
|
| Secondary | Procedural Pain | degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine | Posted | Mean | Standard Error | units on a scale | immediately following procedure |
|
|
|
| Secondary | Patient Preference | Patient preference for RFA or Varithena® using e-diary | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 4 |
| 34 |
| EG001 | Radiofrequency Ablation | Varithena® treatment in accordance with full prescribing information and instructions for use Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care. | 0 | 34 | 0 | 34 | 3 | 34 |
| Phlebitis | Vascular disorders | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |