Venous RefluxWAVESNCT02585726

Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES)

A study testing SP-402 VenaSeal™ Closure System in people with Venous Reflux, run by Lake Washington Vascular at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Venous Reflux
What is being tested?: SP-402 VenaSeal™ Closure System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Jul 2017
Phase: Interventional
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 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Reflux in at least one target vein;
One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling;
CEAP classification of C2 (if symptomatic) through C5;

Who cannot join

Current, regular use of systemic anticoagulation;
Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans;
Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment;
Known hypercoagulable disorder;
Pregnant or breast feeding at enrollment;
Known sensitivity to cyanoacrylate adhesives;
Venous treatment in the contralateral limb within the last 30 days, or who require contralateral treatment within three months;
Planned to undergo additional ipsilateral treatments on the same leg within 3 months following treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lake Washington Vascular, PLLC
Bellevue, Washington, 98004

Other trials in United States

About this study

Official title: Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES

Conditions: Venous Reflux
Being tested: SP-402 VenaSeal™ Closure System
Keywords: Varicose Veins, Great Saphenous Vein, Venous Insufficiency
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.

SP-402 VenaSeal™ Closure SystemDevice
Also called VenaSeal™
A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..

Study groups in NCT02585726
Study group	Role	What they receive
Historical Control with Propensity Analysis	Active comparator	Not described Receives: Device: SP-402 VenaSeal™ Closure System
VenaSeal Treatment Arm	Experimental	Not described Receives: Device: SP-402 VenaSeal™ Closure System

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
Measured: 1 month

Secondary outcomes (11)

CC of the PTVS, as assessed by duplex ultrasound
Measured: 1 week and 3 months after treatment
CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound
Measured: 1 month and 3 months after the index procedure
Quality of life as measured by the venous clinical severity scores (rVCSS)
Measured: 1 and 3 months after treatment
Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)
Measured: 1 and 3 months after treatment
Quality of life as measured by the EQ-5D
Measured: 1 and 3 months after treatment
Return to normal activities and return to work; day of procedure is day 0
Measured: 1 week, 1 month
Need for adjunctive treatment
Measured in case report form (yes or no, and if yes, the Investigator will specify what the adjunctive measure is).
Measured: 3 months
Safety and adverse event for below the knee greater saphenous vein treatment
Measured: 1 week, 1 month, 3 months
Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter
Measured: 1 week, 1 month, 3 months
Patient satisfaction
At selected visits, the subject will complete a brief questionnaire rating satisfaction with treatment provided and whether the subject would undergo the treatment again.
Measured: 1 week, 1 month, 3 months
CC of TVS, expressed on a per-segment basis
Measured: 1 month and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Jul 2017

First posted23 Oct 2015 (estimated)
Study startOct 2015
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Venous RefluxStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02585726
Sponsor's protocol ID: 2015-01
Acronym: WAVES
Status last verified: Mar 2018
First submitted: 22 Oct 2015
Last updated: 16 Mar 2018
Results posted: No

Publications

Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
PubMed 21536172
Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
PubMed 15723761
van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
PubMed 18692348
Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.
van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins--a review of literature. Semin Vasc Surg. 2014 Jun;27(2):118-36. doi: 10.1053/j.semvascsurg.2015.02.002. Epub 2015 Feb 18.
PubMed 25868763
Guex JJ. Endovenous chemical (and physical) treatments for varices: what's new? Phlebology. 2014 May;29(1 suppl):45-48. doi: 10.1177/0268355514526331. Epub 2014 May 19.
PubMed 24843085
Davies HO, Popplewell M, Darvall K, Bate G, Bradbury AW. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology. 2016 May;31(4):234-40. doi: 10.1177/0268355515595194. Epub 2015 Jul 9.
PubMed 26163507
El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith GE, Campbell B, Chetter IC. Systematic review of compression following treatment for varicose veins. Br J Surg. 2015 Jun;102(7):719-25. doi: 10.1002/bjs.9788. Epub 2015 Apr 2.
PubMed 25833417
Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555.
PubMed 21725957
Bootun R, Lane TR, Davies AH. The advent of non-thermal, non-tumescent techniques for treatment of varicose veins. Phlebology. 2016 Feb;31(1):5-14. doi: 10.1177/0268355515593186. Epub 2015 Jun 30.
PubMed 26130051
Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
PubMed 25650040
Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015 Jul;30(6):397-404. doi: 10.1177/0268355514532455. Epub 2014 Apr 30.
PubMed 24789750
Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.
PubMed 26993674
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.
PubMed 20875713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
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Active, not recruitingPhase 3
Endovenous Laser Ablation With 1940 nm Versus 1470 nm
Varicose Veins of Lower Limb, Great Saphenous Vein (GSV) With Venous Reflux Disease
RecruitingObservational study
HEMOVAR Study on Hemorrhoids and Varicose Veins
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Active, not recruiting
Venclose digiRF System Post Market Study
Venous Reflux, Chronic Venous Insufficiency
Recruiting
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Varicose Veins, Chronic Venous Insufficiency

All Venous Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES
ClinicalTrials.gov ID: NCT02585726
Acronym / sponsor ID: WAVES / 2015-01
Conditions: Venous Reflux
Keywords: Varicose Veins, Great Saphenous Vein, Venous Insufficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Lake Washington VascularUniversity, hospital or other
Collaborators: Syntactx
Study start: Oct 2015
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 23 Oct 2015 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Historical Control with Propensity Analysis	Active comparator	Device: SP-402 VenaSeal™ Closure System
VenaSeal Treatment Arm	Experimental	Device: SP-402 VenaSeal™ Closure System

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Reflux in at least one target vein;
One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling;
CEAP classification of C2 (if symptomatic) through C5;

Key exclusion criteria (8 listed)

Current, regular use of systemic anticoagulation;
Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans;
Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment;
Known hypercoagulable disorder;
Pregnant or breast feeding at enrollment;

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
SP-402 VenaSeal™ Closure SystemAlso: VenaSeal™A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..	Device	Historical Control with Propensity Analysis, VenaSeal Treatment Arm

Primary outcome

Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
Time frame: 1 month
CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.

11 secondary outcomes

CC of the PTVS, as assessed by duplex ultrasound
Time frame: 1 week and 3 months after treatment
CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound
Time frame: 1 month and 3 months after the index procedure
Quality of life as measured by the venous clinical severity scores (rVCSS)
Time frame: 1 and 3 months after treatment
Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: 1 and 3 months after treatment
Quality of life as measured by the EQ-5D
Time frame: 1 and 3 months after treatment
Return to normal activities and return to work; day of procedure is day 0
Time frame: 1 week, 1 month
Need for adjunctive treatment
Time frame: 3 months
Safety and adverse event for below the knee greater saphenous vein treatment
Time frame: 1 week, 1 month, 3 months
Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter
Time frame: 1 week, 1 month, 3 months
Patient satisfaction
Time frame: 1 week, 1 month, 3 months
CC of TVS, expressed on a per-segment basis
Time frame: 1 month and 3 months

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 16 Mar 2018.
Background: PubMed 21536172Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
Background: PubMed 15723761Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
Background: PubMed 18692348van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
BackgroundGeza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.
Background: PubMed 25868763van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins--a review of literature. Semin Vasc Surg. 2014 Jun;27(2):118-36. doi: 10.1053/j.semvascsurg.2015.02.002. Epub 2015 Feb 18.
Background: PubMed 24843085Guex JJ. Endovenous chemical (and physical) treatments for varices: what's new? Phlebology. 2014 May;29(1 suppl):45-48. doi: 10.1177/0268355514526331. Epub 2014 May 19.
Background: PubMed 26163507Davies HO, Popplewell M, Darvall K, Bate G, Bradbury AW. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology. 2016 May;31(4):234-40. doi: 10.1177/0268355515595194. Epub 2015 Jul 9.
Background: PubMed 25833417El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith GE, Campbell B, Chetter IC. Systematic review of compression following treatment for varicose veins. Br J Surg. 2015 Jun;102(7):719-25. doi: 10.1002/bjs.9788. Epub 2015 Apr 2.
Background: PubMed 21725957Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555.
Background: PubMed 26130051Bootun R, Lane TR, Davies AH. The advent of non-thermal, non-tumescent techniques for treatment of varicose veins. Phlebology. 2016 Feb;31(1):5-14. doi: 10.1177/0268355515593186. Epub 2015 Jun 30.
Background: PubMed 25650040Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
Background: PubMed 24789750Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015 Jul;30(6):397-404. doi: 10.1177/0268355514532455. Epub 2014 Apr 30.

Related trials for Venous Reflux

Active, not recruiting
Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
Vascular Access Devices, Catheters
Active, not recruitingPhase 3
Endovenous Laser Ablation With 1940 nm Versus 1470 nm
Varicose Veins of Lower Limb, Great Saphenous Vein (GSV) With Venous Reflux Disease
RecruitingObservational study
HEMOVAR Study on Hemorrhoids and Varicose Veins
Varicose Veins of Lower Limb, Hemorrhoids
Active, not recruiting
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Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SP-402 VenaSeal™ Closure System in people with 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 3 inclusion and 8 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 16 Mar 2018. 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?

Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure. (time frame: 1 month). 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 NCT02585726, which also lists 14 linked publications.

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 16 Mar 2018.