Back to resultsEU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Primary Purpose
Chronic Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Venclose RF System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring GSV, superficial vein reflux, venous reflux, venous insufficiency, varicose veins
Eligibility Criteria
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.
Sites / Locations
- Venenzentrum am Bruehl
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Venclose RF System
Arm Description
Treatment of great saphenous vein (GSV) using Venclose RF System
Outcomes
Primary Outcome Measures
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
Secondary Outcome Measures
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)
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)
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
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)
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)
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Presence of Complications From GSV Intervention
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04236245
Brief Title
EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Official Title
EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
August 2, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venclose, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
GSV, superficial vein reflux, venous reflux, venous insufficiency, varicose veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venclose RF System
Arm Type
Other
Arm Description
Treatment of great saphenous vein (GSV) using Venclose RF System
Intervention Type
Device
Intervention Name(s)
Venclose RF System
Other Intervention Name(s)
RF ablation, EVSRF
Intervention Description
Treatment of great saphenous vein (GSV) using Venclose RF System
Primary Outcome Measure Information:
Title
Vein Occlusion Rate
Description
Percentage of limbs with occlusion of the treated vein
Time Frame
3 days
Title
Vein Occlusion Rate
Description
Percentage of limbs with occlusion of the treated vein
Time Frame
3 months
Title
Vein Occlusion Rate
Description
Percentage of limbs with occlusion of the treated vein
Time Frame
6 months
Title
Vein Occlusion Rate
Description
Percentage of limbs with occlusion of the treated vein
Time Frame
12 months
Title
Reflux-free Rate
Description
Percentage of limbs without reflux in the treated vein
Time Frame
3 days
Title
Reflux-free Rate
Description
Percentage of limbs without reflux in the treated vein
Time Frame
3 months
Title
Reflux-free Rate
Description
Percentage of limbs without reflux in the treated vein
Time Frame
6 months
Title
Reflux-free Rate
Description
Percentage of limbs without reflux in the treated vein
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Description
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
Title
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Description
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
Title
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Description
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
Title
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Description
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
Title
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Description
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
Title
Venous Clinical Severity Score (VCSS)
Description
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Time Frame
Baseline
Title
Venous Clinical Severity Score (VCSS)
Description
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Time Frame
3 days
Title
Venous Clinical Severity Score (VCSS)
Description
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Time Frame
3 months
Title
Venous Clinical Severity Score (VCSS)
Description
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Time Frame
6 months
Title
Venous Clinical Severity Score (VCSS)
Description
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Time Frame
12 months
Title
Presence of Complications From GSV Intervention
Description
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Time Frame
up to 3 days
Title
Presence of Complications From GSV Intervention
Description
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Time Frame
3 months
Title
Presence of Complications From GSV Intervention
Description
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Time Frame
6 months
Title
Presence of Complications From GSV Intervention
Description
Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Mattausch, Dr. med
Organizational Affiliation
Venenzentrum am Bruehl
Official's Role
Principal Investigator
Facility Information:
Facility Name
Venenzentrum am Bruehl
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20875713
Citation
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.
Results Reference
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EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
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