Varicose VeinsVALUENCT04006184
Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation
An observational study of Varicose Veins and Venous Reflux, run by Lake Washington Vascular at 1 site in United States.
Trial summary
This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Venous Reflux, Venous Insufficiency
- What is being tested?
- Chart review
- How many people
- 547 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2019to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 327 limbs treated with Cyanoacrylate Closure and 327 limbs treated with Endovenous Thermal Ablation for symptomatic varicose veins and incompetence of the great or small saphenous vein, or both veins.
Who may be able to join
- Limb with saphenous vein incompetence, treated with one of the following:
- VenaSeal ™ Endovenous Laser Ablation Radiofrequency Ablation
- CEAP Clinical Class between 2-5
- Limb treated from October 1st, 2015-present
- At least 2 months of follow-up post index procedure
- Treatment of either the great saphenous vein (GSV), the small saphenous vein (SSV), or both. Treatment of accessory saphenous veins (ASV) is allowed as long as either the GSV, SSV, or both the GSV and SSV were treated as well in that limb at the index procedure.
Who cannot join
- Limb treatment of the accessory saphenous vein (ASV) without concomitant great saphenous vein (GSV) and/or small saphenous vein (SSV) treatment
- Limb treatment for reasons other than symptomatic varicose veins
- Limbs without follow-up information at least 2 months following the index procedure
- Subjects who participated in another clinical trial as part of their saphenous vein treatment
- Investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -
Trial locations and contacts
1 site in 1 country.
United States1 site
Lake Washington Vascular, PLLC
Bellevue, Washington, 98004
About this study
Official title: Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy
This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).
Read the detailed description
This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared.
Some of the secondary aims of this study include:
- To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment.
- To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups.
- To assess the need for adjunctive therapies.
- To record and compare retrospectively the adverse events between the two groups.
- Conditions
- Varicose Veins, Venous Reflux, Venous Insufficiency
- Being tested
- Chart review
- Keywords
- Venaseal, Symptomatic Varicose Veins
- Medical subject headings
- Varicose Veins, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart reviewOther
Retrospective review of medical records at a single site with six physicians
| Study group | Role | What they receive |
|---|---|---|
| Endovenous Thermal Ablation | Limbs treated with either radiofrequency ablation or endovenous laser ablation Receives: Other: Chart review | |
| Cyanoacrylate Closure | Limbs treated with cyanoacrylate closure system Receives: Other: Chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjunctive phlebectomy
Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure
Measured: Through 6 months of index procedure
Cost of Treatment
A cost analysis will be performed calculating the total cost of treatment between groups
Measured: Through six months of index procedure
Secondary outcomes (4)
Severity of Disease
Assess potential change in clinical class using the Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class
Measured: At treatment through six months of index procedure
Severity of Disease
Assess potential change in clinical severity score using the Revised Venous Clinical Severity Score (rVCSS).
Measured: At treatment through six months of index procedure
Utilization of adjunctive treatments
Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need
Measured: Through six months of index procedure
Adverse events reported during clinic visits
If adverse events were reported and documented in chart, these will be collected and categorized to assess for comparison between groups
Measured: Though six months of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start14 Jun 2019
- Primary completion30 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lake Washington Vascular
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Kathleen D Gibson, MD, Principal investigator, Lake Washington Vascular, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006184
- Sponsor's protocol ID
- GG2019/01
- Acronym
- VALUE
- Status last verified
- Oct 2019
- First submitted
- 29 Jun 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibson K, Glorieux K, Minjarez R, Foster E, Neradilek M, Polissar N. Adjunctive procedure utilization and cost comparison of cyanoacrylate versus endothermal ablation for saphenous vein reflux. Vasc Med. 2026 Jun;31(3):360-368. doi: 10.1177/1358863X261434818. Epub 2026 Jun 10.
PubMed 42267768
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy
- ClinicalTrials.gov ID
- NCT04006184
- Acronym / sponsor ID
- VALUE / GG2019/01
- Conditions
- Varicose Veins, Venous Reflux, Venous Insufficiency
- Keywords
- Venaseal, Symptomatic Varicose Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Lake Washington VascularUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).
Detailed description
This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared.
Some of the secondary aims of this study include:
- To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment.
- To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups.
- To assess the need for adjunctive therapies.
- To record and compare retrospectively the adverse events between the two groups.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovenous Thermal Ablation | – | Other: Chart reviewLimbs treated with either radiofrequency ablation or endovenous laser ablation |
| Cyanoacrylate Closure | – | Other: Chart reviewLimbs treated with cyanoacrylate closure system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 327 limbs treated with Cyanoacrylate Closure and 327 limbs treated with Endovenous Thermal Ablation for symptomatic varicose veins and incompetence of the great or small saphenous vein, or both veins.
Key inclusion criteria (6 listed)
- Limb with saphenous vein incompetence, treated with one of the following:
- VenaSeal ™ Endovenous Laser Ablation Radiofrequency Ablation
- CEAP Clinical Class between 2-5
- Limb treated from October 1st, 2015-present
- At least 2 months of follow-up post index procedure
Key exclusion criteria (5 listed)
- Limb treatment of the accessory saphenous vein (ASV) without concomitant great saphenous vein (GSV) and/or small saphenous vein (SSV) treatment
- Limb treatment for reasons other than symptomatic varicose veins
- Limbs without follow-up information at least 2 months following the index procedure
- Subjects who participated in another clinical trial as part of their saphenous vein treatment
- Investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -
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 |
|---|---|---|
| Chart reviewRetrospective review of medical records at a single site with six physicians | Other | Cyanoacrylate Closure, Endovenous Thermal Ablation |
Primary outcome
Adjunctive phlebectomy
Time frame: Through 6 months of index procedure
Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure
Cost of Treatment
Time frame: Through six months of index procedure
A cost analysis will be performed calculating the total cost of treatment between groups
4 secondary outcomes
Severity of Disease
Time frame: At treatment through six months of index procedure
Severity of Disease
Time frame: At treatment through six months of index procedure
Utilization of adjunctive treatments
Time frame: Through six months of index procedure
Adverse events reported during clinic visits
Time frame: Though six months of index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 42267768Gibson K, Glorieux K, Minjarez R, Foster E, Neradilek M, Polissar N. Adjunctive procedure utilization and cost comparison of cyanoacrylate versus endothermal ablation for saphenous vein reflux. Vasc Med. 2026 Jun;31(3):360-368. doi: 10.1177/1358863X261434818. Epub 2026 Jun 10.
- 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.
Kathleen D Gibson, MD principal investigator
Lake Washington Vascular, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Venous Reflux, run by Lake Washington Vascular at 1 site in United States.
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 3 Oct 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adjunctive phlebectomy (time frame: Through 6 months of index procedure). The study lists 2 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 NCT04006184, 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 3 Oct 2019.