Trial Outcomes & Findings for A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency (NCT NCT03311269)
NCT ID: NCT03311269
Last Updated: 2022-03-02
Results Overview
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.
TERMINATED
PHASE2
19 participants
12 weeks
2022-03-02
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Baseline characteristics by cohort
| Measure |
ClariVein RES 1% Injection
n=10 Participants
Sodium Tetradecyl Sulfate 1% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection
|
ClariVein RES 3% Injection
n=9 Participants
Sodium Tetradecyl Sulfate 3% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
25.6 kg/m2
STANDARD_DEVIATION 4.54 • n=99 Participants
|
27.1 kg/m2
STANDARD_DEVIATION 5.35 • n=107 Participants
|
26.3 kg/m2
STANDARD_DEVIATION 4.86 • n=206 Participants
|
|
Ultrasound Parameters at Screening: Leg Assessed
Right
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ultrasound Parameters at Screening: Leg Assessed
Left
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Retrograde Flow
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Patient-Reported Symptoms 7-Day Symptom Questionnaire (Average Daily Total Symptom Score
|
10.6 units on a scale
STANDARD_DEVIATION 3.39 • n=99 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 4.18 • n=107 Participants
|
10.9 units on a scale
STANDARD_DEVIATION 3.76 • n=206 Participants
|
|
Saphenous Vein Reflux
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Length of Vein Section to be Treated
|
37.8 centimeters (cm)
STANDARD_DEVIATION 6.49 • n=99 Participants
|
34.6 centimeters (cm)
STANDARD_DEVIATION 15.27 • n=107 Participants
|
36.3 centimeters (cm)
STANDARD_DEVIATION 11.29 • n=206 Participants
|
|
Diameter of Vein Section to be Treated
|
5.41 centimeters (cm)
STANDARD_DEVIATION 0.845 • n=99 Participants
|
9.08 centimeters (cm)
STANDARD_DEVIATION 7.490 • n=107 Participants
|
7.15 centimeters (cm)
STANDARD_DEVIATION 5.369 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
ClariVein RES 1% Injection
n=10 Participants
Sodium Tetradecyl Sulfate 1% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection
|
ClariVein RES 3% Injection
n=9 Participants
Sodium Tetradecyl Sulfate 3% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
|
|---|---|---|
|
Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.
|
7.2 units on a scale
Standard Deviation 3.00
|
6.2 units on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: 12 weeksEvaluated 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
Outcome measures
| Measure |
ClariVein RES 1% Injection
n=10 Participants
Sodium Tetradecyl Sulfate 1% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection
|
ClariVein RES 3% Injection
n=9 Participants
Sodium Tetradecyl Sulfate 3% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
|
|---|---|---|
|
Elimination of Saphenous Vein Reflux
Vein Closure : Yes
|
5 Participants
|
9 Participants
|
|
Elimination of Saphenous Vein Reflux
Vein Closure : No
|
5 Participants
|
0 Participants
|
|
Elimination of Saphenous Vein Reflux
Vein Closure : Missing
|
0 Participants
|
0 Participants
|
|
Elimination of Saphenous Vein Reflux
Vein Competency : Yes
|
2 Participants
|
0 Participants
|
|
Elimination of Saphenous Vein Reflux
Vein Competency : No
|
3 Participants
|
0 Participants
|
|
Elimination of Saphenous Vein Reflux
Vein Competency : Missing
|
0 Participants
|
0 Participants
|
|
Elimination of Saphenous Vein Reflux
Vein Competency: No open segments > 5cm
|
5 Participants
|
9 Participants
|
|
Elimination of Saphenous Vein Reflux
Saphenous Vein Reflux: Non-Responder
|
3 Participants
|
0 Participants
|
|
Elimination of Saphenous Vein Reflux
Saphenous Vein Reflux: Responder
|
7 Participants
|
9 Participants
|
Adverse Events
ClariVein RES 3% Injection
ClariVein RES 1% Injection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ClariVein RES 3% Injection
n=9 participants at risk
Sodium Tetradecyl Sulfate 3% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection
|
ClariVein RES 1% Injection
n=10 participants at risk
Sodium Tetradecyl Sulfate 1% Injection single administration
ClariVein RES: ClariVein system
Sodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/9 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
22.2%
2/9 • Number of events 2 • 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.
|
0.00%
0/10 • 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.
|
|
General disorders
Infusion Site Bruising
|
11.1%
1/9 • Number of events 1 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place