Status:
COMPLETED
Venclose RF Ablation System for the Treatment of IPVs
Lead Sponsor:
Venclose, Inc.
Conditions:
Chronic Venous Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
Eligibility Criteria
Inclusion
- Patient is \>= 18 years.
- IPVs to be treated have an outward flow duration of \>= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg.
- IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle.
- Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated.
- Is able to ambulate.
- Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
- Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.
Exclusion
- Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
- Has thrombus in the vein segment to be treated.
- Has untreated critical limb ischemia from peripheral arterial disease.
- Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
- Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively.
- Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
- Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
- Has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study.
- Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 30 days following the study procedure.
- Is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation
Key Trial Info
Start Date :
May 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04386785
Start Date
May 23 2020
End Date
May 13 2021
Last Update
May 27 2022
Active Locations (1)
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1
Vein Center of East Texas at CardioStream
Tyler, Texas, United States, 75701