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Study was terminated for administrative reasons
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VICARES is a prospective randomized, controlled, multi-center, double blind study treating venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium Tetradecyl Sulfate (STS) solution utilizing the ClariVein system.
Approximately 50 subjects diagnosed with an incompetent saphenous vein will be randomized to either 1% STS or 3% STS solution delivered by the ClariVein system under ultrasound guidance.
Study duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClariVein RES 1% Injection | Active Comparator | Sodium Tetradecyl Sulfate 1% Injection single administration |
|
| ClariVein RES 3% Injection | Active Comparator | Sodium Tetradecyl Sulfate 3% Injection single administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClariVein RES | Device | ClariVein system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms. | The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, & a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of Saphenous Vein Reflux | Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein > 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow > 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark H Meissner, MD | Vascular and Endovascular Surgery Clinic at UWMC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Vascular Experts | Darien | Connecticut | 06820 | United States | ||
| Capitol Vein and Laser Centers |
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| ID | Title | Description |
|---|---|---|
| FG000 | ClariVein RES 1% Injection | Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection |
| FG001 | ClariVein RES 3% Injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2017 |
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| Sodium Tetradecyl Sulfate 1% Injection | Drug | Sodium Tetradecyl Sulfate STS 1% Injection |
|
|
| Sodium Tetradecyl Sulfate 3% Injection | Drug | Sodium Tetradecyl Sulfate 3% Injection |
|
|
| 12 weeks |
| Frederick |
| Maryland |
| 21702 |
| United States |
| Southeastern Surgical Associates | Hyannis | Massachusetts | 02601 | United States |
| Englegwood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Lake Washington Vascular, PLLC | Bellevue | Washington | 98004 | United States |
Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ClariVein RES 1% Injection | Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection |
| BG001 | ClariVein RES 3% Injection | Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection |
| BG002 | 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Ultrasound Parameters at Screening: Leg Assessed | Count of Participants | Participants |
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| Retrograde Flow | Count of Participants | Participants |
| ||||||||||||||||||
| Patient-Reported Symptoms 7-Day Symptom Questionnaire (Average Daily Total Symptom Score | 7 Day Symptom Questionnaire. Subjects self reported each symptom on a daily basis for 7 consecutive days prior to study day 1. Response to each system was rated on a common 4-point response scale, with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Mean is calculated across daily responses for each of the symptoms. Weekly average score was calculated if at least 4 daily scores were present. Daily total symptom score is derived as sum of responses across all symptoms (range 5 to 20). More than 2 items missing, then no score | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Saphenous Vein Reflux | Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein > 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow > 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux | Count of Participants | Participants |
| |||||||||||||||||
| Length of Vein Section to be Treated | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||||
| Diameter of Vein Section to be Treated | Mean | Standard Deviation | centimeters (cm) |
|
| 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 | Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms. | The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, & a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Secondary | Elimination of Saphenous Vein Reflux | Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein > 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow > 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux | Posted | Count of Participants | Participants | 12 weeks |
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AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.
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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 | ClariVein RES 1% Injection | Sodium Tetradecyl Sulfate 1% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection | 0 | 10 | 0 | 10 | 1 | 10 |
| EG001 | ClariVein RES 3% Injection | Sodium Tetradecyl Sulfate 3% Injection single administration ClariVein RES: ClariVein system Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection | 0 | 9 | 0 | 9 | 3 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment | Blister (From Compression Sock) |
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| Thrombophlebitis Superficial | Vascular disorders | MedDRA 20.1 | Systematic Assessment | superficial thrombophlebitis. |
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| Infusion Site Bruising | General disorders | MedDRA 20.1 | Systematic Assessment | Bruising at Access Site |
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A total of 19 subjects were enrolled in the study. The study was terminated for administrative reasons; there were no safety or efficacy concerns. It was determined by the sponsor that the Phase 3 protocol, which is designed to closely mimic the Phase 2 protocol, would be adequate to collect safety and efficacy assessments with minor adjustments.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms. Lorraine Hanley, MBA | Vascular Inisights, LLC | 617-519-1109 | lorraine.hanley@merit.com |
| May 15, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012981 | Sodium Tetradecyl Sulfate |
| D007267 | Injections |
| C046259 | 3-methoxy-14,15-methyleneestra-1,3,5-triene-17-ol |
| ID | Term |
|---|---|
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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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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| Left |
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| Other |
The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately. |
| All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. | t-test, 2 sided | One-Sample | 0.011 | This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 1% Injection treatment group. | Mean Difference (Final Values) | -3.4 | 2-Sided | 95 | -5.8 | -1.0 | Other | The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately. |
| All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. | t-test, 2 sided | One-Sample | 0.010 | This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 3% Injection treatment group. | Mean Difference (Final Values) | -5.1 | 2-Sided | 95 | -8.7 | -1.6 | Other | The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately. |
| All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. | ANCOVA | 0.531 | This p-value corresponds to the difference between treatment groups (ClariVein RES 1% Injection versus ClariVein RES 3% Injection). | Least-Squares Mean Difference | -1.2 | 2-Sided | 95 | -3.7 | 1.3 | Other | An ANCOVA was performed to compare the change from baseline for ClariVein RES 1% Injection versus ClariVein RES 3% Injection with treatment as the class variable and with baseline score as the covariate |
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