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VenaSeal for Venous Reflux Disease
N/A
Waitlist Available
Led By Manjit Gohel, MD
Research Sponsored by Medtronic Endovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treatable refluxing segment of target vein(s) 10 cm in length or longer
Patient is ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up index procedure through 60 months (through 12 months for venaseal vs. surgical stripping study)
Awards & highlights
Study Summary
This trial is testing a new way to treat venous disease, which is a common condition that can cause pain, swelling, and other issues.
Who is the study for?
Adults over 18 with venous reflux in superficial veins, confirmed by ultrasound. They must have a vein diameter of at least 3mm and be able to follow the study's procedures. Pregnant or breastfeeding women, non-ambulatory individuals, those with certain health conditions like heart failure or severe liver dysfunction, or recent COVID-19 infection are excluded.Check my eligibility
What is being tested?
The trial compares the VenaSeal™ Closure System against traditional treatments for varicose veins: surgical stripping and endothermal ablation (ETA). It aims to determine which method is more effective for treating different stages of superficial venous disease.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the VenaSeal adhesive, skin irritation or inflammation at treatment sites, bruising, nerve damage leading to numbness or tingling sensations, and potential complications from heat-based ETA such as burns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My target vein for treatment is 10 cm or longer.
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I am 18 years old or older.
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I understand what participating in the study involves and can give my consent.
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I have confirmed vein issues in my legs that cause symptoms or skin changes.
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I am eligible for treatment with the VenaSeal™ system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ index procedure through 60 months (through 12 months for venaseal vs. surgical stripping study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~index procedure through 60 months (through 12 months for venaseal vs. surgical stripping study)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
Time to ulcer healing (For VLU study)
Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
+1 moreSecondary outcome measures
Additional adverse events
Adverse events (AEs) occurring in the target limb
Anatomic closure of primary target vein
+25 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: VenaSeal™ Closure System VLU StudyExperimental Treatment1 Intervention
CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System
Group II: VenaSeal™ Closure SystemExperimental Treatment1 Intervention
CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping
Group III: Endothermal Ablation (ETA)Active Control1 Intervention
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA
Group IV: Surgical StrippingActive Control1 Intervention
CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)
Find a Location
Who is running the clinical trial?
Medtronic EndovascularLead Sponsor
68 Previous Clinical Trials
14,455 Total Patients Enrolled
Manjit Gohel, MDPrincipal InvestigatorAddenbrooke's Hospital, UK
Kathleen Gibson, MDPrincipal InvestigatorLake Washington Vascular, US
2 Previous Clinical Trials
289 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have surgical stripping or VenaSeal due to specific health reasons.My target vein for treatment is 10 cm or longer.I am 18 years old or older.I am a woman who could be pregnant or breastfeeding.I currently have or had COVID-19 in the last 3 months and haven't fully recovered.I have a clot in a vein near the surface of my skin.You have a large, curved ulcer on your leg that cannot be fully captured in one photo.You are currently taking part in another study for a new drug or device that could affect the results of this study.I understand what participating in the study involves and can give my consent.I am willing and able to follow the trial's schedule for check-ups.I am eligible for treatment with VenaSeal and ETA.I am eligible for VenaSeal or surgical vein stripping.You have a history of allergies, including cyanoacrylate adhesives, that could make you more likely to have an allergic reaction to the adhesive used in the study.I do not have severe health issues that could affect my participation in the study.I have confirmed vein issues in my legs that cause symptoms or skin changes.My blood flow in my legs is poor, confirmed by tests.I need surgery on the opposite or same limb, or any surgery within 3 months after the procedure.I have a confirmed deep vein blockage in my limb.I cannot walk on my own.I am eligible for treatment with the VenaSeal™ system.
Research Study Groups:
This trial has the following groups:- Group 1: Endothermal Ablation (ETA)
- Group 2: Surgical Stripping
- Group 3: VenaSeal™ Closure System
- Group 4: VenaSeal™ Closure System VLU Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any North American health centers conducting this investigation?
"This clinical trial is offered in 10 different medical centres, such as PIMA Heart and Vascular situated in Tucson, Orion Medical based out of Pasadena, New york-Presbyterian Hospital/Weill Cornell Medical Center located in the Big Apple, and seven other sites."
Answered by AI
Are there still vacancies available in this clinical trial?
"Clinicaltrials.gov confirms that this medical experiment is currently registering participants. It was initially announced on February 5th 2020 and the latest update happened on October 11th 2022."
Answered by AI
What is the cap on total participants in this clinical trial?
"806 eligible participants are necessitated to conduct the trial, sponsored by Medtronic Endovascular. To facilitate this study, multiple medical sites have been chosen - such as PIMA Heart and Vascular in Tucson, Arizona and Orion Medical in Pasadena, Texas."
Answered by AI
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