Venclose RF Ablation System for the Treatment of IPVs

May 4, 2022 updated by: Venclose, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Tyler, Texas, United States, 75701
        • Vein Center of East Texas at CardioStream

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-arm: Endovascular thermal ablation in IPV
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3-day post-procedure
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.
15-day post-procedure
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.
30-day post-procedure
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.
Day of procedure
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.
3-day post ablation
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.
15-day post ablation
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.
30-day post ablation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3-day post-procedure follow-up
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.
15-day post-procedure
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.
30-day post-procedure
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.
3-day post-procedure
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.
15-day post-procedure
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.
30-day post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Venclose, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Carr, MD, Vein Center of East Texas at CardioStream

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL-VAV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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