Status:
COMPLETED
Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)
Lead Sponsor:
Englewood Hospital and Medical Center
Conditions:
Great Saphenous Vein Insufficiency
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
- CEAP-clinical classification ≥ 2
- Physical condition allowing ambulation after the procedure.
- Agree to comply with the Clinical investigation plan and follow-up schedule of the study
- Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface.
- Age over 22 years at the time of enrollment.
- No acute venous thrombosis.
- No complete or near complete deep vein post-thrombotic disease.
- Patient has signed and understood the written informed consent.
- Exclusion criteria
- Patient is pregnant
- Known allergic reaction to anesthetics to be used.
- Legally incapacitated or imprisoned patients
- Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
- Patient participating in another clinical trial involving an investigational drug or device.
- Ankle-brachial index \<7 (ABI)
- Undergoing active anticoagulant therapy within the last 6 months
- Diameter of the treated anatomical segment below ≤ 2mm
- \-
Exclusion
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05193643
Start Date
March 23 2022
End Date
January 31 2023
Last Update
April 19 2023
Active Locations (1)
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1
Englewood Health
Englewood, New Jersey, United States, 07631