A Phase 2 interventional study of ClariVein RES and Sodium Tetradecyl Sulfate 1% Injection in Venous Insufficiency, sponsored by Vascular Insights, LLC. Terminated at 5 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Vascular Insights, LLC (part of Merit Medical Systems, Inc.) · Phase 2, Interventional, and Treatment
Among 43 studies in Venous Insufficiency with a site in United States — 1 open to participants now, 3 under way, none of them phase 3. Venous Insufficiency · United States.
Among the 43 studies in Venous Insufficiency with a site in United States, this one is the 27th largest by enrollment of the 35 interventional ones that give a count, is one of 3 that started in 2017, is one of 4 in phase 2, and was the 30th registered.
162 studies on the registry are indexed under Venous Insufficiency; 14 are open to participants now.
Browse Venous Insufficiency studies →1 of the 43 studies in Venous Insufficiency with a site in United States is open now. Recruiting first, the newest first:
University of Maryland, Baltimore · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Venous Insufficiency studies recruiting now, 6 set no upper age limit and 2 stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 1 · Phase 4 2
First in 1999; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 19 is below the median of 60 across 127 interventional studies indexed under Venous Insufficiency.
Median enrollment 50 across the 35 interventional studies, 49 across the 8 observational. Of the 34 that completed or were terminated, 18 (53%) have results posted.
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18 of 43 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Vascular Insights, LLC as lead sponsor.
Vascular Insights, LLC has 1 study filed under Venous Insufficiency — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 43 studies in Venous Insufficiency with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sodium Tetradecyl Sulfate 1% Injection single administration
Device: ClariVein RES · Drug: Sodium Tetradecyl Sulfate 1% Injection
Sodium Tetradecyl Sulfate 3% Injection single administration
Device: ClariVein RES · Drug: Sodium Tetradecyl Sulfate 3% Injection
ClariVein system
Sodium Tetradecyl Sulfate STS 1% Injection
Also known as: STS 1%
Sodium Tetradecyl Sulfate 3% Injection
Also known as: STS 3%
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.
Time frame: 12 weeks
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
Time frame: 12 weeks
| Milestone | ClariVein RES 1% Injection | ClariVein RES 3% Injection |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
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.
| units on a scale | ClariVein RES 1% Injection | ClariVein RES 3% Injection |
|---|---|---|
| Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms. | 7.2 ± 3.00 | 6.2 ± 1.87 |
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
| Participants | ClariVein RES 1% Injection | ClariVein RES 3% Injection |
|---|---|---|
| Vein Closure : Yes | 5 | 9 |
| Vein Closure : No | 5 | 0 |
| Vein Closure : Missing | 0 | 0 |
| Vein Competency : Yes | 2 | 0 |
| Vein Competency : No | 3 | 0 |
| Vein Competency : Missing | 0 | 0 |
| Vein Competency: No open segments > 5cm | 5 | 9 |
| Saphenous Vein Reflux: Non-Responder | 3 | 0 |
| Saphenous Vein Reflux: Responder | 7 | 9 |
Collected over 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.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ClariVein RES 1% Injection | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| ClariVein RES 3% Injection | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Event | ClariVein RES 1% Injection | ClariVein RES 3% Injection |
|---|---|---|
| Thrombophlebitis SuperficialVascular disorders | 0/10 | 2/9 |
| Infusion Site BruisingGeneral disorders | 1/10 | 1/9 |
| BlisterSkin and subcutaneous tissue disorders | 1/10 | 0/9 |
| Age, Categorical(Participants) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 8 | 16 |
| >=65 years | 2 | 1 | 3 |
| Sex: Female, Male(Participants) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 9 | 8 | 17 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 8 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| United States | 10 | 9 | 19 |
| Body Mass Index (BMI)(kg/m2) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| Mean | 25.6 ± 4.54 | 27.1 ± 5.35 | 26.3 ± 4.86 |
| Ultrasound Parameters at Screening: Leg Assessed(Participants) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| Right | 7 | 3 | 10 |
| Left | 3 | 6 | 9 |
| Retrograde Flow(Participants) | ClariVein RES 1% Injection | ClariVein RES 3% Injection | Total |
|---|---|---|---|
| Count of participants | 10 | 9 | 19 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in May 2018, 7 months.
Results were first posted in Mar 2022, 3 years 9 months after primary completion.
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Studies of the drug tested here: Sodium Tetradecyl Sulfate