Varicose VeinsPhase 4COMFORTNCT02462720

COMFORT: A Multicenter, Open-label, Randomized, Crossover Study

A Phase 4 study testing Varithena® and Radiofrequency ablation in people with Varicose Veins, run by Boston Scientific Corporation at 4 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Varicose Veins
What is being tested?: Varithena® and Radiofrequency ablation
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 4 sitesUnited States
Study dates: May 2015to Mar 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women; age 18 to 75 years
Bilateral incompetence of SFJ (reflux >1 second on duplex ultrasonography) associated with incompetence of the GSV in both legs
GSV diameter >5 mm measured from the superficial epigastric vein to 10 cm below the SFJ while in a standing position in both legs
Eligible to receive RFA treatment and Varithena® treatment
CEAP C2-C5 (inclusive)
Patient is participating in usual work and home activities with no changes anticipated for the duration of the study
Ability to comprehend and sign an informed consent and complete study questionnaires written in English
Ability to reliably use an electronic diary to record pain and analgesic/opioid use in accordance with the protocol

Who cannot join

Prior GSV treatment in either leg
Non-venous source of pain in either leg that could confound the results of the study
Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study
History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound
Deep venous reflux unless clinically insignificant in comparison to superficial reflux
Inability to wear post-procedure compression bandaging and stockings

Show all 18Show fewer

Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
Major co-existing disease (e.g., malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
Contraindications to Varithena® (e.g., acute thromboembolic disease) or RFA according to the manufacturer's prescribing information
Varithena® contraindication due to known allergy to polidocanol
RFA contraindication due to veins being too large
RFA Contraindication due to veins being too tortuous
Known allergic response to polidocanol and/or multiple allergic reactions
Current or history of alcohol or drug abuse
Pregnant or lactating women
Women of childbearing potential not using effective contraception for at least one month prior to study treatment and/or unwilling to continue birth control for the duration of the study
Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Venous Institute of Buffalo
Amherst, New York, 14226
Lake Washington Vascular
Bellevue, Washington, 98004
Midwest Institute for Minimally Invasive Therapies
Melrose Park, Illinois, 60160
Coastal Vascular and Interventional, PLLC
Pensacola, Florida, 32503

Other trials in United States

About this study

Official title: Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation

The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.

Read the detailed description

A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.

Conditions: Varicose Veins
Being tested: Varithena®, Radiofrequency ablation
Medical subject headings: Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Varithena®Drug
Also called Polidocanol Solution, 180 mg/18 mL (10 mg/mL)
Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablationDevice
Also called RFA
Radiofrequency ablation conducted per physicians' standard of care.

Study groups in NCT02462720
Study group	Role	What they receive
Varithena®, then Radiofrequency Ablation	Experimental	Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used. This was followed by RFA treatment. Receives: Drug: Varithena®; Device: Radiofrequency ablation
Radiofrequency ablation then Varithena	Active comparator	RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. This was followed by treatment with Varithena. Receives: Drug: Varithena®; Device: Radiofrequency ablation

What is being measured

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

Pain
14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.
Measured: 14 day average (0-100)

Secondary outcomes (2)

Procedural Pain
degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine
Measured: immediately following procedure
Patient Preference
Patient preference for RFA or Varithena® using e-diary
Measured: 8 weeks

Timeline

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

May 2015Mar 2016

First posted4 Jun 2015 (estimated)
Study startMay 2015
Primary completionDec 2015
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Varicose VeinsStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02462720
Sponsor's protocol ID: VAP.VV018
Acronym: COMFORT
Status last verified: Apr 2021
First submitted: 20 May 2015
Last updated: 21 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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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All Varicose Veins trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation
ClinicalTrials.gov ID: NCT02462720
Acronym / sponsor ID: COMFORT / VAP.VV018
Conditions: Varicose Veins
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Dec 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 4 Jun 2015 (estimated)
Results: Posted 23 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.

Detailed description

A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.

Study design

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

Arm	Type	Receives
Varithena®, then Radiofrequency Ablation	Experimental	Drug: Varithena®, Device: Radiofrequency ablationVarithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used. This was followed by RFA treatment.
Radiofrequency ablation then Varithena	Active comparator	Drug: Varithena®, Device: Radiofrequency ablationRFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. This was followed by treatment with Varithena.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men and women; age 18 to 75 years
Bilateral incompetence of SFJ (reflux >1 second on duplex ultrasonography) associated with incompetence of the GSV in both legs
GSV diameter >5 mm measured from the superficial epigastric vein to 10 cm below the SFJ while in a standing position in both legs
Eligible to receive RFA treatment and Varithena® treatment
CEAP C2-C5 (inclusive)

Key exclusion criteria (18 listed)

Prior GSV treatment in either leg
Non-venous source of pain in either leg that could confound the results of the study
Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study
History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound
Deep venous reflux unless clinically insignificant in comparison to superficial reflux

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
Varithena®Also: Polidocanol Solution, 180 mg/18 mL (10 mg/mL)Varithena® treatment in accordance with full prescribing information and instructions for use	Drug	Radiofrequency ablation then Varithena, Varithena®, then Radiofrequency Ablation
Radiofrequency ablationAlso: RFARadiofrequency ablation conducted per physicians' standard of care.	Device	Radiofrequency ablation then Varithena, Varithena®, then Radiofrequency Ablation

Primary outcome

Pain
Time frame: 14 day average (0-100)
14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.

2 secondary outcomes

Procedural Pain
Time frame: immediately following procedure
Patient Preference
Time frame: 8 weeks

Results and safety

Results posted to the registry on 23 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varithena® First Then Radiofrequency Ablation	18	18
Radiofrequency Ablation First Than Varithena	17	17

Primary outcome: Pain

Time frame: 14 day average (0-100). Mean (Standard Error). Unit: units on a scale

Measure	Varithena® n = 33	Radiofrequency Ablation n = 33
Value	11.3 (2.90)	9.5 (2.90)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: A period of time ending at Week 4 (day 32). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varithena®	0 of 34 (0%)	4 of 34 (11.8%)	0 of 34
Radiofrequency Ablation	0 of 34 (0%)	3 of 34 (8.8%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingObservational study
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Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
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Not yet recruiting
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Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
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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.

David Wright, MD study director

BTG International Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Varithena® and Radiofrequency ablation in people with Varicose Veins, run by Boston Scientific Corporation at 4 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 8 inclusion and 18 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain (time frame: 14 day average (0-100)). 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 NCT02462720.

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 21 Apr 2021.