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CompletedNCT04236245Updated Apr 4, 2022Results posted

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

An interventional study of Venclose RF System in Chronic Venous Insufficiency, sponsored by Venclose, Inc.. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-04.

Sponsored by Venclose, Inc. (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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 After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.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.

02

Conditions studied

  • Chronic Venous Insufficiency

Keywords

  • GSV
  • superficial vein reflux
  • venous reflux
  • venous insufficiency
  • varicose veins
03

In context

Venous Insufficiency

193 studies on the registry are indexed under Venous Insufficiency; 15 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 142 interventional studies indexed under Venous Insufficiency.

Browse Venous Insufficiency studies →

Lead sponsor

Venclose, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

First submitted before Venclose, Inc. became part of Becton, Dickinson and Company.

Browse Venclose, Inc. studies →All Becton, Dickinson and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    Venclose RF System

    Treatment of great saphenous vein (GSV) using Venclose RF System

    Device: Venclose RF System

Interventions

  • DeviceVenclose RF System

    Treatment of great saphenous vein (GSV) using Venclose RF System

    Also known as: RF ablation, EVSRF

06

What researchers measure

Primary outcomes

  1. Vein Occlusion Rate

    Percentage of limbs with occlusion of the treated vein

    Time frame: 3 days

  2. Vein Occlusion Rate

    Percentage of limbs with occlusion of the treated vein

    Time frame: 3 months

  3. Vein Occlusion Rate

    Percentage of limbs with occlusion of the treated vein

    Time frame: 6 months

  4. Vein Occlusion Rate

    Percentage of limbs with occlusion of the treated vein

    Time frame: 12 months

  5. Reflux-free Rate

    Percentage of limbs without reflux in the treated vein

    Time frame: 3 days

  6. Reflux-free Rate

    Percentage of limbs without reflux in the treated vein

    Time frame: 3 months

  7. Reflux-free Rate

    Percentage of limbs without reflux in the treated vein

    Time frame: 6 months

  8. Reflux-free Rate

    Percentage of limbs without reflux in the treated vein

    Time frame: 12 months

Secondary outcomes

  1. 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)

    Time frame: Baseline

  2. 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)

    Time frame: 3 days

  3. 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

    Time frame: 3 months

  4. 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)

    Time frame: 6 months

  5. 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)

    Time frame: 12 months

  6. Venous Clinical Severity Score (VCSS)

    Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

    Time frame: Baseline

  7. Venous Clinical Severity Score (VCSS)

    Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

    Time frame: 3 days

  8. Venous Clinical Severity Score (VCSS)

    Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

    Time frame: 3 months

  9. Venous Clinical Severity Score (VCSS)

    Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

    Time frame: 6 months

  10. Venous Clinical Severity Score (VCSS)

    Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

    Time frame: 12 months

  11. Presence of Complications From GSV Intervention

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

    Time frame: up to 3 days

  12. Presence of Complications From GSV Intervention

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

    Time frame: 3 months

  13. Presence of Complications From GSV Intervention

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

    Time frame: 6 months

  14. Presence of Complications From GSV Intervention

    Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

    Time frame: 12 months

07

Results

Posted Mar 10, 2022

Participant flow

Participant flow — Overall Study
MilestoneVenclose RF System
Started25
Completed25
Not completed0

Outcome measures

PrimaryVein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame:
3 days
Reported as:
Count of units · limbs
Vein Occlusion Rate
limbsVenclose RF System
Complete Occlusion29
Segmental Recanalization0
Complete Recanalization0
PrimaryVein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame:
3 months
Reported as:
Count of units · Limbs
Vein Occlusion Rate
LimbsVenclose RF System
Complete Occlusion28
Segmental Recanalization1
Complete Recanalization0
PrimaryVein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame:
6 months
Reported as:
Count of units · Limbs
Vein Occlusion Rate
LimbsVenclose RF System
Complete Occlusion28
Segmental Recanalization1
Complete Recanalization0
PrimaryVein Occlusion Rate

Percentage of limbs with occlusion of the treated vein

Time frame:
12 months
Reported as:
Count of units · Limbs
Vein Occlusion Rate
LimbsVenclose RF System
Complete Occlusion28
Segmental Recanalization1
Complete Recanalization0
PrimaryReflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame:
3 days
Reported as:
Count of units · Limbs
Reflux-free Rate
LimbsVenclose RF System
No reflux along treated GSV29
Reflux along treated GSV0
PrimaryReflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame:
3 months
Reported as:
Count of units · Limbs
Reflux-free Rate
LimbsVenclose RF System
No reflux along treated GSV28
Reflux along treated GSV1
PrimaryReflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame:
6 months
Reported as:
Count of units · Limbs
Reflux-free Rate
LimbsVenclose RF System
No reflux along treated GSV28
Reflux along treated GSV1
PrimaryReflux-free Rate

Percentage of limbs without reflux in the treated vein

Time frame:
12 months
Reported as:
Count of units · Limbs
Reflux-free Rate
LimbsVenclose RF System
No reflux along treated GSV28
Reflux along treated GSV1
SecondaryClinical 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)

Time frame:
Baseline
Reported as:
Count of units · Limbs
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
LimbsVenclose RF System
C0: No visible or palpable signs of venous disease0
C1: Telangiectasies or reticular veins0
C2: Varicose veins0
C3: Edema24
C4a: Pigmentation or eczema4
C4b: Lipodermatosclerosis or atrophie blanche0
C5: Healed venous ulcer1
C6: Active venous ulcer0
SecondaryClinical 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)

Time frame:
3 days
Reported as:
Count of units · Limbs
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
LimbsVenclose RF System
C0: No visible or palpable signs of venous disease0
C1: Telangiectasies or reticular veins1
C2: Varicose veins0
C3: Edema24
C4a: Pigmentation or eczema3
C4b: Lipdermatosclerosis or atrophie blanche0
C5: Healed venous ulcer1
C6: Active venous ulcer0
SecondaryClinical 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

Time frame:
3 months
Reported as:
Count of units · Limbs
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
LimbsVenclose RF System
C0: No visible or palpable signs of venous disease1
C1: Telangiectasies or reticular veins11
C2: Varicose veins10
C3: Edema4
C4a: Pigmentation or eczema2
C4b: Lipodermatosclerosis or atrophie blanche0
C5: Healed venous ulcer1
C6: Active venous ulcer0
SecondaryClinical 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)

Time frame:
6 months
Reported as:
Count of units · Limbs
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
LimbsVenclose RF System
C0: No visible or palpable signs of venous disease1
C1: Telangiectasies or reticular veins19
C2: Varicose veins5
C3: Edema1
C4a: Pigmentation or eczema2
C4b: Lipodermatosclerosis or atrophie blanche0
C5: Healed venous ulcer1
C6: Active venous ulcer0
SecondaryClinical 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)

Time frame:
12 months
Reported as:
Count of units · Limbs
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
LimbsVenclose RF System
C0: No visible or palpable signs of venous disease1
C1: Telangiectasies or reticular veins21
C2: Varicose veins3
C3: Edema1
C4a: Pigmentation or eczema2
C4b: Lipodermatosclerosis or atrophie blanche0
C5: Healed venous ulcer1
C6: Active venous ulcer0
SecondaryVenous Clinical Severity Score (VCSS)

Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

Time frame:
Baseline
Reported as:
Mean · score on a scale
Venous Clinical Severity Score (VCSS)
score on a scaleVenclose RF System
Venous Clinical Severity Score (VCSS)4.4 ± 1.8
SecondaryVenous Clinical Severity Score (VCSS)

Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

Time frame:
3 days
Reported as:
Mean · score on a scale
Venous Clinical Severity Score (VCSS)
score on a scaleVenclose RF System
Venous Clinical Severity Score (VCSS)5.9 ± 1.1
SecondaryVenous Clinical Severity Score (VCSS)

Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

Time frame:
3 months
Reported as:
Mean · score on a scale
Venous Clinical Severity Score (VCSS)
score on a scaleVenclose RF System
Venous Clinical Severity Score (VCSS)1.6 ± 1.3
SecondaryVenous Clinical Severity Score (VCSS)

Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

Time frame:
6 months
Reported as:
Mean · score on a scale
Venous Clinical Severity Score (VCSS)
score on a scaleVenclose RF System
Venous Clinical Severity Score (VCSS)0.7 ± 1.0
SecondaryVenous Clinical Severity Score (VCSS)

Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))

Time frame:
12 months
Reported as:
Mean · score on a scale
Venous Clinical Severity Score (VCSS)
score on a scaleVenclose RF System
Venous Clinical Severity Score (VCSS)0.6 ± 0.9
SecondaryPresence of Complications From GSV Intervention

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

Time frame:
up to 3 days
Reported as:
Number · Limbs
Presence of Complications From GSV Intervention
LimbsVenclose RF System
Allergic reaction to local anesthesia0
Allergic reaction to device0
Vein perforation0
Thermal skin injury0
Skin discoloration or pigmentation0
Infection0
Neurological injury0
Paresthesia1
Superficial venous thrombophlebitis0
Edema0
Ecchymosis0
Hematoma0
Erythema0
EHIT II (non-occlusive DVT)1
Deep vein thrombosis (DVT) or pulmonary embolism (PE)0
SecondaryPresence of Complications From GSV Intervention

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

Time frame:
3 months
Reported as:
Number · Limbs
Presence of Complications From GSV Intervention
LimbsVenclose RF System
Allergic reaction to local anesthesia0
Allergic reaction to device0
Vein perforation0
Thermal skin injury0
Skin discoloration or pigmentation0
Infection0
Neurological injury0
Paresthesia0
Superficial venous thrombophlebitis0
Edema0
Ecchymosis0
Hematoma0
Erythema0
EHIT II (non-occlusive DVT)0
Deep vein thrombosis (DVT) or pulmonary embolism (PE)0
SecondaryPresence of Complications From GSV Intervention

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

Time frame:
6 months
Reported as:
Number · Limbs
Presence of Complications From GSV Intervention
LimbsVenclose RF System
Allergic reaction to local anesthesia0
Allergic reaction to device0
Vein perforation0
Thermal skin injury0
Skin discoloration or pigmentation0
Infection0
Neurological injury0
Paresthesia0
Superficial venous thrombophlebitis0
Edema0
Ecchymosis0
Hematoma0
Erythema0
EHIT II (non-occlusive DVT)0
Deep vein thrombosis (DVT) or pulmonary embolism (PE)0
SecondaryPresence of Complications From GSV Intervention

Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention

Time frame:
12 months
Reported as:
Number · Limbs
Presence of Complications From GSV Intervention
LimbsVenclose RF System
Allergic reaction to local anesthesia0
Allergic reaction to device0
Vein perforation0
Thermal skin injury0
Skin discoloration or pigmentation0
Infection0
Neurological injury0
Paresthesia0
Superficial venous thrombophlebitis0
Edema0
Ecchymosis0
Hematoma0
Erythema0
EHIT II (non-occlusive DVT)0
Deep vein thrombosis (DVT) or pulmonary embolism (PE)0

Adverse events

Collected over Adverse event data were collected from time of treatment through one year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Venclose RF System0/25 (0%)0/25 (0%)5/25 (20%)
Most frequent other events
Most frequent other events
EventVenclose RF System
Non-occlusive DVTVascular disorders2/25
Muscle vein thrombosisVascular disorders1/25
PainVascular disorders1/25
LymphedemaBlood and lymphatic system disorders1/25
ParesthesiaNervous system disorders1/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)Venclose RF System
Mean54 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)Venclose RF System
Female20
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Venclose RF System
Hispanic or Latino0
Not Hispanic or Latino25
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Venclose RF System
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White25
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Venclose RF System
Germany25
08

Study locations

1 site
  • Venenzentrum am Bruehl
    Leipzig, 04109, Germany
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 7, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2020 to primary completion in Aug 2021, 14 months.

Results were first posted in Mar 2022, 7 months after primary completion.

Of 57 interventional studies with no phase under Venous Insufficiency, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2020
First posted
Jan 22, 2020
StartActual
May 11, 2020
Primary completionActual
Aug 2, 2021
CompletionActual
Aug 2, 2021
Results first posted
Mar 10, 2022
Last update
Apr 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04236245
Lead sponsor
Venclose, Inc.
Responsible party
Sponsor
First posted
Jan 22, 2020
Start date
May 11, 2020
Primary completion
Aug 2, 2021
Completion
Aug 2, 2021
Results posted
Mar 10, 2022
Last update
Apr 4, 2022

Study contacts

Thomas Mattausch, Dr. med
principal investigator · Venenzentrum am Bruehl

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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