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

Varicose Veins Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462720
• Other study ID #: VAP.VV018
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Drug:
• Varithena®
Varithena® treatment in accordance with full prescribing information and instructions for use

Device:
• Radiofrequency ablation
Radiofrequency ablation conducted per physicians' standard of care.

Locations

Country	Name	City	State
United States	Venous Institute of Buffalo	Amherst	New York
United States	Lake Washington Vascular	Bellevue	Washington
United States	Midwest Institute for Minimally Invasive Therapies	Melrose Park	Illinois
United States	Coastal Vascular and Interventional, PLLC	Pensacola	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 day average (0-100)
Secondary	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	immediately following procedure
Secondary	Patient Preference	Patient preference for RFA or Varithena® using e-diary	8 weeks