Chronic Venous InsufficiencyNCT04236245

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

A study testing Venclose RF System in people with Chronic Venous Insufficiency, run by Venclose, Inc. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Venous Insufficiency
What is being tested?: Venclose RF System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteGermany
Study dates: 11 May 2020to 2 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Venenzentrum am Bruehl
Leipzig, 04109

Other trials in Germany

About this study

Read the 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.

Conditions: Chronic Venous Insufficiency
Being tested: Venclose RF System
Keywords: GSV, superficial vein reflux, venous reflux, venous insufficiency, varicose veins
Medical subject headings: Venous Insufficiency, Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Venclose RF SystemDevice
Also called RF ablation, EVSRF
Treatment of great saphenous vein (GSV) using Venclose RF System

Study groups in NCT04236245
Study group	Role	What they receive
Venclose RF System	Other	Treatment of great saphenous vein (GSV) using Venclose RF System Receives: Device: Venclose RF System

What is being measured

The primary outcome is the main question the study is designed to answer.

Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Measured: 3 days
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Measured: 3 months
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Measured: 6 months
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Measured: 12 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Measured: 3 days
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Measured: 3 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Measured: 6 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Measured: 12 months

Secondary outcomes (14)

Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
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)
Measured: Baseline
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
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)
Measured: 3 days
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
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
Measured: 3 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
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)
Measured: 6 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
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)
Measured: 12 months
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Measured: Baseline
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Measured: 3 days
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Measured: 3 months
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Measured: 6 months
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Measured: 12 months
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Measured: up to 3 days
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Measured: 3 months
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Measured: 6 months
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 20202 Aug 2021

First posted22 Jan 2020
Study start11 May 2020
Primary completion2 Aug 2021
Study completion2 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04236245
Sponsor's protocol ID: VENC17A
Status last verified: Mar 2022
First submitted: 14 Jan 2020
Last updated: 4 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.
PubMed 20875713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Venous Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
ClinicalTrials.gov ID: NCT04236245
Acronym / sponsor ID: VENC17A
Conditions: Chronic Venous Insufficiency
Keywords: GSV, superficial vein reflux, venous reflux, venous insufficiency, varicose veins
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Venclose, Inc.Industry (pharma, biotech, devices)
Study start: 11 May 2020 (actual)
Primary completion: 2 Aug 2021 (actual)
Study completion: 2 Aug 2021 (actual)
First posted: 22 Jan 2020 (actual)
Results: Posted 10 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Venclose RF System	Other	Device: Venclose RF SystemTreatment of great saphenous vein (GSV) using Venclose RF System

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Venclose RF SystemAlso: RF ablation, EVSRFTreatment of great saphenous vein (GSV) using Venclose RF System	Device	Venclose RF System

Primary outcome

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

14 secondary outcomes

Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time frame: Baseline
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time frame: 3 days
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time frame: 3 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time frame: 6 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Time frame: 12 months
Venous Clinical Severity Score (VCSS)
Time frame: Baseline
Venous Clinical Severity Score (VCSS)
Time frame: 3 days
Venous Clinical Severity Score (VCSS)
Time frame: 3 months
Venous Clinical Severity Score (VCSS)
Time frame: 6 months
Venous Clinical Severity Score (VCSS)
Time frame: 12 months
Presence of Complications From GSV Intervention
Time frame: up to 3 days
Presence of Complications From GSV Intervention
Time frame: 3 months
Presence of Complications From GSV Intervention
Time frame: 6 months
Presence of Complications From GSV Intervention
Time frame: 12 months

Results and safety

Results posted to the registry on 10 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Venclose RF System	25	25

Primary outcome: Vein Occlusion Rate

Time frame: 3 days. Count of units. Unit: limbs

Measure	Venclose RF System n = 25
Complete Occlusion	29
Segmental Recanalization	0
Complete Recanalization	0

Population analysed: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.

Primary outcome: Vein Occlusion Rate

Time frame: 3 months. Count of units. Unit: Limbs

Measure	Venclose RF System n = 25
Complete Occlusion	28
Segmental Recanalization	1
Complete Recanalization	0

Population analysed: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.

Primary outcome: Vein Occlusion Rate

Time frame: 6 months. Count of units. Unit: Limbs

Measure	Venclose RF System n = 25
Complete Occlusion	28
Segmental Recanalization	1
Complete Recanalization	0

Population analysed: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.

Primary outcome: Vein Occlusion Rate

Time frame: 12 months. Count of units. Unit: Limbs

Measure	Venclose RF System n = 25
Complete Occlusion	28
Segmental Recanalization	1
Complete Recanalization	0

Population analysed: Twenty-five subjects were treated, 4 of whom were treated bilaterally, for a total of 29 limbs treated.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from time of treatment through one year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Venclose RF System	0 of 25 (0%)	5 of 25 (20%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20875713Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Mattausch, Dr. med principal investigator

Venenzentrum am Bruehl

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Venclose RF System in people with Chronic Venous Insufficiency, run by Venclose, Inc. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vein Occlusion Rate (time frame: 3 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04236245, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.