EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

March 24, 2022 updated by: Venclose, Inc.
This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein.

The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.

After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • 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

      • Leipzig, Germany, 04109
        • Venenzentrum am Bruehl

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

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is male or female and 18 to 80 years old (inclusive) at time of enrollment (signing of consent).
  • Subject has significant venous reflux by Duplex Ultrasound (DUS), defined as reverse flow with reflux duration greater than 0.5 seconds after the Valsalva maneuver or distal augmentation while the patient is standing or in reverse Trendelenburg position.
  • Subject is eligible for endovascular treatment, as determined by the treating investigator.
  • Subject's general physical condition allows for a significant amount of ambulation after the procedure, as determined by the treating investigator.
  • Subject is willing and able to complete study requirements, including all follow-up visits and assessments.
  • Subject voluntarily provides written informed consent to participate in this study.

Exclusion Criteria:

  • There is evidence of old or fresh thrombus in the subject's diseased vein segment to be treated, as determined by Duplex Ultrasound (DUS) within 2 weeks prior to the index procedure.
  • In the judgment of the treating investigator heat energy delivery to the subject would be contraindicated.
  • Subject is concurrently participating in another interventional clinical trial.
  • Subject is pregnant or plans to be pregnant or lactating at the time of the treatment procedure.
  • Subject has known or suspected allergies or contraindications to any general or local anesthetic agents and/or any antibiotic medication that cannot be adequately pre-treated.

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
Intervention / Treatment
Other: Venclose RF System
Treatment of great saphenous vein (GSV) using Venclose RF System
Treatment of great saphenous vein (GSV) using Venclose RF System
Other Names:
  • RF ablation, EVSRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vein Occlusion Rate
Time Frame: 3 days
Percentage of limbs with occlusion of the treated vein
3 days
Vein Occlusion Rate
Time Frame: 3 months
Percentage of limbs with occlusion of the treated vein
3 months
Vein Occlusion Rate
Time Frame: 6 months
Percentage of limbs with occlusion of the treated vein
6 months
Vein Occlusion Rate
Time Frame: 12 months
Percentage of limbs with occlusion of the treated vein
12 months
Reflux-free Rate
Time Frame: 3 days
Percentage of limbs without reflux in the treated vein
3 days
Reflux-free Rate
Time Frame: 3 months
Percentage of limbs without reflux in the treated vein
3 months
Reflux-free Rate
Time Frame: 6 months
Percentage of limbs without reflux in the treated vein
6 months
Reflux-free Rate
Time Frame: 12 months
Percentage of limbs without reflux in the treated vein
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: Baseline
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Baseline
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 3 days
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
3 days
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 3 months
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer
3 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 6 months
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
6 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time Frame: 12 months
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
12 months
Venous Clinical Severity Score (VCSS)
Time Frame: Baseline
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Baseline
Venous Clinical Severity Score (VCSS)
Time Frame: 3 days
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
3 days
Venous Clinical Severity Score (VCSS)
Time Frame: 3 months
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
3 months
Venous Clinical Severity Score (VCSS)
Time Frame: 6 months
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
6 months
Venous Clinical Severity Score (VCSS)
Time Frame: 12 months
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
12 months
Presence of Complications From GSV Intervention
Time Frame: up to 3 days
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
up to 3 days
Presence of Complications From GSV Intervention
Time Frame: 3 months
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
3 months
Presence of Complications From GSV Intervention
Time Frame: 6 months
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
6 months
Presence of Complications From GSV Intervention
Time Frame: 12 months
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
12 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Thomas Mattausch, Dr. med, Venenzentrum am Bruehl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

May 11, 2020

Primary Completion (Actual)

August 2, 2021

Study Completion (Actual)

August 2, 2021

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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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