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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation conducted per physicians' standard of care.
Coastal Vascular and Interventional, PLLC
Pensacola, Florida, United States
Midwest Institute for Minimally Invasive Therapies
Melrose Park, Illinois, United States
Venous Institute of Buffalo
Amherst, New York, United States
Lake Washington Vascular
Bellevue, Washington, United States
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.
Time frame: 14 day average (0-100)
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
Time frame: immediately following procedure
Patient Preference
Patient preference for RFA or Varithena® using e-diary
Time frame: 8 weeks
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