Venclose RF Ablation System for the Treatment of IPVs

NCT04386785 | Completed Results FDA Device

• 1 other identifier: CL-VAV-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Safety: AEs, SAEs, ADEs, SADEs, UADEs

  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-day post-procedure

• Safety: AEs, SAEs, ADEs, SADEs, UADEs

  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.

  15-day post-procedure

• Safety: AEs, SAEs, ADEs, SADEs, UADEs

  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.

  30-day post-procedure

• Effectiveness: Technical Success

  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.

  Day of procedure

• Effectiveness: Successful Access and Entry Into the IPV

  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.

  3-day post ablation

• Effectiveness: Technical Success

  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.

  15-day post ablation

• Effectiveness: Technical Success

  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.

  30-day post ablation

Secondary Outcomes (6)

• Acute Ablation Success

  3-day post-procedure follow-up

• Acute Ablation Success

  15-day post-procedure

• Acute Ablation Success

  30-day post-procedure

• Reflux

  3-day post-procedure

• Reflux

  15-day post-procedure

Study Arms (1)

Single-arm: Endovascular thermal ablation in IPV

EXPERIMENTAL

Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins

Interventions

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.

Single-arm: Endovascular thermal ablation in IPV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Venclose, Inc.: lead

Study Sites (1)

Vein Center of East Texas at CardioStream

Tyler, Texas, 75701, United States

Location

Results Point of Contact

• Title: Mai-Ly Wilcox
• Organization: Venclose

mwilcox@venclose.com

415-254-1930

Study Officials

• Jeffrey Carr, MD

  Vein Center of East Texas at CardioStream

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 13, 2020
• Study Start: May 23, 2020
• Primary Completion: April 13, 2021
• Study Completion: May 13, 2021
• Last Updated: May 27, 2022
• Results First Posted: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)