EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2020
CompletedStudy Start
First participant enrolled
May 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2021
CompletedResults Posted
Study results publicly available
March 10, 2022
CompletedApril 4, 2022
March 1, 2022
1.2 years
January 14, 2020
February 15, 2022
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
3 days
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
3 months
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
6 months
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein
12 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
3 days
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
3 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
6 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein
12 months
Secondary Outcomes (14)
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
Baseline
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
3 days
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
3 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
6 months
Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification
12 months
- +9 more secondary outcomes
Study Arms (1)
Venclose RF System
OTHERTreatment of great saphenous vein (GSV) using Venclose RF System
Interventions
Treatment of great saphenous vein (GSV) using Venclose RF System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Venclose, Inc.lead
Study Sites (1)
Venenzentrum am Bruehl
Leipzig, 04109, Germany
Related Publications (1)
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.
PMID: 20875713BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mai-Ly Wilcox
- Organization
- Venclose, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Mattausch, Dr. med
Venenzentrum am Bruehl
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2020
First Posted
January 22, 2020
Study Start
May 11, 2020
Primary Completion
August 2, 2021
Study Completion
August 2, 2021
Last Updated
April 4, 2022
Results First Posted
March 10, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share