Skip to main content
OpenTrials
Completed

NCT Number: NCT04386785

Venclose RF Ablation System for the Treatment of IPVs

A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Venous Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vein Center of East Texas at CardioStream

Tyler, Texas, 75701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins

Device

The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.

Primary outcomes

  1. Safety: AEs, SAEs, ADEs, SADEs, UADEs

    Time frame: 3-day post-procedure

    Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.

  2. Safety: AEs, SAEs, ADEs, SADEs, UADEs

    Time frame: 15-day post-procedure

    Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.

  3. Safety: AEs, SAEs, ADEs, SADEs, UADEs

    Time frame: 30-day post-procedure

    Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.

  4. Effectiveness: Technical Success

    Time frame: Day of procedure

    Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

  5. Effectiveness: Successful Access and Entry Into the IPV

    Time frame: 3-day post ablation

    Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

  6. Effectiveness: Technical Success

    Time frame: 15-day post ablation

    Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

  7. Effectiveness: Technical Success

    Time frame: 30-day post ablation

    Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.

Secondary outcomes

  1. Acute Ablation Success

    Time frame: 3-day post-procedure follow-up

    The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.

  2. Acute Ablation Success

    Time frame: 15-day post-procedure

    The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.

  3. Acute Ablation Success

    Time frame: 30-day post-procedure

    The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure.

  4. Reflux

    Time frame: 3-day post-procedure

    Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.

  5. Reflux

    Time frame: 15-day post-procedure

    Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.

  6. Reflux

    Time frame: 30-day post-procedure

    Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point.

Sponsors and collaborators

Lead sponsor

Venclose, Inc.

Industry

Registry information

Official study title

Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 13, 2020
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.