Venclose RF Ablation System for the Treatment of IPVs

NCT ID: NCT04386785

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-23
• Study Completion Date: 2021-05-13

Brief Summary

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

Conditions

Chronic Venous Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-arm: Endovascular thermal ablation in IPV

Group Type: EXPERIMENTAL

Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins

Intervention Type: 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.

Interventions

Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Venclose, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Carr, MD

Role: PRINCIPAL_INVESTIGATOR

Vein Center of East Texas at CardioStream

Locations

Vein Center of East Texas at CardioStream

Tyler, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CL-VAV-001

Identifier Type: -

Identifier Source: org_study_id