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

NCT02462720 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-04-21

Study results available
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Summary

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

Conditions

  • Varicose Veins

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • David Wright, MD · BTG International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02462720 on ClinicalTrials.gov