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Search / Trial NCT04386785

Venclose RF Ablation System for the Treatment of IPVs

Launched by VENCLOSE, INC. · May 11, 2020

Trial Information

Current as of July 24, 2025

Completed

Keywords

ClinConnect Summary

No description provided

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

About Venclose, Inc.

Venclose, Inc. is a pioneering biotechnology company dedicated to advancing innovative medical solutions for the treatment of venous diseases. With a focus on developing minimally invasive therapies, Venclose aims to enhance patient outcomes and improve the quality of care in vascular health. The company is committed to rigorous clinical research and collaboration with healthcare professionals to bring safe and effective products to market, addressing unmet medical needs and transforming the standard of care in the management of venous disorders.

Locations

Tyler, Texas, United States

Patients applied

0 patients applied

Trial Officials

Jeffrey Carr, MD

Principal Investigator

Vein Center of East Texas at CardioStream

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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