Varicose VeinsNew-WAVESNCT04146168
Lake Washington Vascular VenaSeal™ Post-Market Evaluation
An observational study of Varicose Veins and Venous Reflux, run by Lake Washington Vascular at 3 sites in United States.
Trial summary
New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Venous Reflux
- What is being tested?
- Ultrasound
- How many people
- 124 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2019to Mar 2020
- 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: Subjects will be recruited from the practice by identification of all patients treated with the Venaseal Closure System from October 2015 to December 31, 2016. This will include 50 prior subjects whom participated in the WAVES trial (ClinicalTrials.gov Identifier: NCT02585726), and up to 75 additional subjects whom also received the treatment with Venaseal but were not enrolled in the WAVES trial. All potential subjects for this study will have received treatment at Lake Washington Vascular, PLLC. Prior WAVES trial subjects initially enrolled will be approached with an introductory letter to be sent via e-mail or physical address. The correspondence will be sent to all potential study subjects explaining the purpose of the study and inviting them to participate. This correspondence will be followed up with a phone contact from study personnel.
Who may be able to join
- 1. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred at least 30 months prior to study; 4. Ability to understand the requirements of the study and to provide informed consent.
- -
Who cannot join
- 1. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure; 2. Patients in whom index procedure information is unavailable; 3. Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included).
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Lake Washington Vascular
Bellevue, Washington, 98004
Kim Glorieux, BS, BS, CCRC, 425-453-1772, kimg@lkwv.com
Kathleen Gibson, MD
- Recruiting
Lake Washington Vascular
Issaquah, Washington, 98027
Kim Glorieux, BS, BS, CCRC, 425-453-1772, kimg@lkwv.com
Kathleen Gibson, MD
- Recruiting
Lake Washington Vascular
Kirkland, Washington, 98034
Kim Glorieux, BS, BS, CCRC, 425-453-1772, kimg@lkwv.com
Kathleen Gibson, MD
About this study
Official title: Clinical and Patient-Centered Outcomes Three Years After Venaseal Treatment: Lake Washington Vascular VenaSeal Post Market Evaluation
New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System
Read the detailed description
New WAVES is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with VenaSeal(TM)/ Cyanoacrylate Adhesive Closure System 3 years post-treatment. All patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.
- Conditions
- Varicose Veins, Venous Reflux
- Being tested
- Ultrasound
- Keywords
- Venaseal, cyanoacrylate closure
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Also called Unilateral ultrasound of Limb
Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| VenaSeal | Complete closure of previously treated veins will be assessed via ultrasound Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Closure of Target Vein(s) at 3 years after index treatment
Complete closure is defined as Doppler Ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm.
Measured: 3 years post treatment
Secondary outcomes (5)
Venous disease severity assessed via Venous Clinical Severity Score
Assessed via the revised Venous Clinical Severity Score (rVCSS). The rVCSS is an Investigator assessment of the severity of venous reflux disease, assessing signs and symptoms such as pain, varicose veins, venous edema, skin pigmentation, induration, and inflammation.
Measured: 3 years post treatment
Clinical Severity via Varicose Vein Questionnaire (AVVQ)
Assessed via Aberdeen Varicose Vein Questionnaire (AVVQ) is a disease specific 13 item questionnaire is used to assess the impact of varicose veins on the quality of life, such as pain caused by varicose veins, and the need to take pain medication.
Measured: 3 years post treatment
Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire
Assessed via EQ-5D Questionnaire. The EQ-5D is a short generic quality of life survey that is commonly used outside of the United States for health technology assessments. The "health state today" question provides an overall assessment along a 20 cm visual analog scale (VAS) with a range from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
Measured: 3 years post treatment
Need for adjunctive treatments
Either at the index procedure or at any point following the index procedure
Measured: 3 years post treatment
Health care utilization
Via chart review and patient questionnaire
Measured: 3 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lake Washington Vascular
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Vascular
- Responsible party
- Sponsor
- Investigators
- Kathleen Gibson, MD, Principal investigator, Lake Washington Vascular, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146168
- Sponsor's protocol ID
- 2019-02
- Acronym
- New-WAVES
- Status last verified
- Oct 2019
- First submitted
- 29 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Patient-Centered Outcomes Three Years After Venaseal Treatment: Lake Washington Vascular VenaSeal Post Market Evaluation
- ClinicalTrials.gov ID
- NCT04146168
- Acronym / sponsor ID
- New-WAVES / 2019-02
- Conditions
- Varicose Veins, Venous Reflux
- Keywords
- Venaseal, cyanoacrylate closure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Lake Washington VascularUniversity, hospital or other
- Collaborators
- Medtronic Vascular
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 31 Oct 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.
New-WAVES Study seeks to expand understanding/results from prior study (NCT02585726). Assessing both clinical outcomes and patient satisfaction after treatment with Venaseal/Cyanoacrylate Adhesive Closure System
Detailed description
New WAVES is an investigator initiated protocol that will assess clinical outcomes and patient satisfaction after treatment with VenaSeal(TM)/ Cyanoacrylate Adhesive Closure System 3 years post-treatment. All patients treated from a multi-provider practice, whom meet protocol inclusion criteria, will be invited to consider participation in this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VenaSeal | – | Diagnostic Test: UltrasoundComplete closure of previously treated veins will be assessed via ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the practice by identification of all patients treated with the Venaseal Closure System from October 2015 to December 31, 2016. This will include 50 prior subjects whom participated in the WAVES trial (ClinicalTrials.gov Identifier: NCT02585726), and up to 75 additional subjects whom also received the treatment with Venaseal but were not enrolled in the WAVES trial. All potential subjects for this study will have received treatment at Lake Washington Vascular, PLLC. Prior WAVES trial subjects initially enrolled will be approached with an introductory letter to be sent via e-mail or physical address. The correspondence will be sent to all potential study subjects explaining the purpose of the study and inviting them to participate. This correspondence will be followed up with a phone contact from study personnel.
Key inclusion criteria (2 listed)
- 1. Age ≥18 years; 2. Treatment of the great, small or accessory saphenous vein or any combination of saphenous veins with the Venaseal Closure System; 3. Treatment occurred at least 30 months prior to study; 4. Ability to understand the requirements of the study and to provide informed consent.
- -
Key exclusion criteria (2 listed)
- 1. Subsequent treatment (such as laser or radiofrequency ablation) of venous disease in targeted vein segment after Venaseal closure; 2. Patients in whom index procedure information is unavailable; 3. Patients unwilling to undergo ultrasound evaluation and clinical examination of the previously treated limb; 4. Limbs that were treated in the VeClose trial (patients who participated in VeClose and later had contralateral limb treatment will be included).
- -
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 |
|---|---|---|
| UltrasoundAlso: Unilateral ultrasound of LimbClosure of previously treated veins (with Venaseal) will be assessed via ultrasound. | Diagnostic test | VenaSeal |
Primary outcome
Complete Closure of Target Vein(s) at 3 years after index treatment
Time frame: 3 years post treatment
Complete closure is defined as Doppler Ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5 cm.
5 secondary outcomes
Venous disease severity assessed via Venous Clinical Severity Score
Time frame: 3 years post treatment
Clinical Severity via Varicose Vein Questionnaire (AVVQ)
Time frame: 3 years post treatment
Quality of Life and Patient Satisfaction of Treatment: EQ-5D Questionnaire
Time frame: 3 years post treatment
Need for adjunctive treatments
Time frame: 3 years post treatment
Health care utilization
Time frame: 3 years post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- 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 Gibson, MD principal investigator
Lake Washington Vascular, PLLC
3 sites 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 3 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 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 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim D Glorieux, BS, BS, CCRC (425-453-1772, kimg@lkwv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Closure of Target Vein(s) at 3 years after index treatment (time frame: 3 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2019.