Trial Outcomes & Findings for Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (NCT NCT05312970)

Last Updated: 2026-03-20

Results Overview

Mean change in points of total score on Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment. VVSymQ scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

Baseline to 3-month post treatment

Results posted on

2026-03-20

Participant Flow

Of 40 enrolled participants, 40 met inclusion criteria. Study was terminated early, and three participants were screened and met inclusion criteria but did not receive treatment.

Participant milestones

Participant milestones
Measure	Varithena® Varithena® (polidocanol injectable foam) 1%	FDA-approved ETA Systems FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Overall Study STARTED	21	19
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varithena® n=21 Participants Varithena® (polidocanol injectable foam) 1%	FDA-approved ETA Systems n=19 Participants FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=154 Participants	0 Participants n=151 Participants	0 Participants n=305 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=154 Participants	12 Participants n=151 Participants	21 Participants n=305 Participants
Age, Categorical >=65 years	12 Participants n=154 Participants	7 Participants n=151 Participants	19 Participants n=305 Participants
Age, Continuous	60.2 years STANDARD_DEVIATION 15.53 • n=154 Participants	57.5 years STANDARD_DEVIATION 13.62 • n=151 Participants	58.9 years STANDARD_DEVIATION 14.53 • n=305 Participants
Sex: Female, Male Female	15 Participants n=154 Participants	14 Participants n=151 Participants	29 Participants n=305 Participants
Sex: Female, Male Male	6 Participants n=154 Participants	5 Participants n=151 Participants	11 Participants n=305 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=154 Participants	0 Participants n=151 Participants	0 Participants n=305 Participants
Race (NIH/OMB) Asian	0 Participants n=154 Participants	2 Participants n=151 Participants	2 Participants n=305 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=154 Participants	0 Participants n=151 Participants	0 Participants n=305 Participants
Race (NIH/OMB) Black or African American	0 Participants n=154 Participants	0 Participants n=151 Participants	0 Participants n=305 Participants
Race (NIH/OMB) White	14 Participants n=154 Participants	15 Participants n=151 Participants	29 Participants n=305 Participants
Race (NIH/OMB) More than one race	1 Participants n=154 Participants	0 Participants n=151 Participants	1 Participants n=305 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=154 Participants	2 Participants n=151 Participants	8 Participants n=305 Participants
Region of Enrollment United States	21 participants n=154 Participants	19 participants n=151 Participants	40 participants n=305 Participants

PRIMARY outcome

Timeframe: Baseline to 3-month post treatment

Population: Due to early study termination, the analysis population consists of a limited number of enrolled participants with available observational data.

Outcome measures

Outcome measures
Measure	Varithena® n=14 Participants Varithena® (polidocanol injectable foam) 1%	FDA-approved ETA Systems n=14 Participants FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)	-3.9 Points of total score Standard Deviation 8.23	-4.7 Points of total score Standard Deviation 4.55

Adverse Events

Varithena®

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

FDA-approved ETA Systems

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Varithena® n=21 participants at risk Varithena® (polidocanol injectable foam) 1% Varithena®: Varithena® (polidocanol injectable foam) 1%	FDA-approved ETA Systems n=19 participants at risk FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems. FDA-approved Endothermal Ablation (ETA) systems: FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Skin and subcutaneous tissue disorders Skin ulcer	4.8% 1/21 • Number of events 1 • Adverse event data were updated up to 1 year.	0.00% 0/19 • Adverse event data were updated up to 1 year.
Vascular disorders Venous thrombosis	4.8% 1/21 • Number of events 1 • Adverse event data were updated up to 1 year.	0.00% 0/19 • Adverse event data were updated up to 1 year.
Skin and subcutaneous tissue disorders Eczema	4.8% 1/21 • Number of events 1 • Adverse event data were updated up to 1 year.	0.00% 0/19 • Adverse event data were updated up to 1 year.

Additional Information

Timothy Keo

Boston Scientific

Phone: 4255993814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place