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

Primary Purpose

Varicose Veins

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varithena®
Radiofrequency ablation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prior GSV treatment in either leg
  2. Non-venous source of pain in either leg that could confound the results of the study
  3. Use of chronic analgesic or opiate medications or medical history that could result in the regular use of pain medications during the study
  4. History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior or active DVT on duplex ultrasound
  5. Deep venous reflux unless clinically insignificant in comparison to superficial reflux
  6. Inability to wear post-procedure compression bandaging and stockings
  7. Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
  8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
  9. 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.)

  10. Contraindications to Varithena® (e.g., acute thromboembolic disease) or RFA according to the manufacturer's prescribing information

    1. Varithena® contraindication due to known allergy to polidocanol
    2. RFA contraindication due to veins being too large
    3. RFA Contraindication due to veins being too tortuous
  11. Known allergic response to polidocanol and/or multiple allergic reactions
  12. Current or history of alcohol or drug abuse
  13. Pregnant or lactating women
  14. 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
  15. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening

Sites / Locations

  • Coastal Vascular and Interventional, PLLC
  • Midwest Institute for Minimally Invasive Therapies
  • Venous Institute of Buffalo
  • Lake Washington Vascular

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Varithena®, then Radiofrequency Ablation

Radiofrequency ablation then Varithena

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Patient Preference
Patient preference for RFA or Varithena® using e-diary

Full Information

First Posted
May 20, 2015
Last Updated
April 19, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02462720
Brief Title
COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
Acronym
COMFORT
Official Title
Multicenter Study to Evaluate Pain Following Treatment of Varicose Vein With Varithena® Compared to Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varithena®, then Radiofrequency Ablation
Arm Type
Experimental
Arm Description
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.
Arm Title
Radiofrequency ablation then Varithena
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Varithena®
Other Intervention Name(s)
Polidocanol Solution, 180 mg/18 mL (10 mg/mL)
Intervention Description
Varithena® treatment in accordance with full prescribing information and instructions for use
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation
Other Intervention Name(s)
RFA
Intervention Description
Radiofrequency ablation conducted per physicians' standard of care.
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
14 day average (0-100)
Secondary Outcome Measure Information:
Title
Procedural Pain
Description
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
Time Frame
immediately following procedure
Title
Patient Preference
Description
Patient preference for RFA or Varithena® using e-diary
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wright, MD
Organizational Affiliation
BTG International Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Vascular and Interventional, PLLC
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Midwest Institute for Minimally Invasive Therapies
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Venous Institute of Buffalo
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Lake Washington Vascular
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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