Venclose RF Ablation System for the Treatment of IPVs

Launched by VENCLOSE, INC. · May 11, 2020

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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