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NCT02462720 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Varicose Veins, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 4
Development phase
35
Enrollment target
4
Study locations

NCT02462720: Completed Phase 4 study of Varicose Veins, sponsored by Boston Scientific Corporation.

NCT02462720 is a Phase 4 study of Varicose Veins that has completed, run by Boston Scientific Corporation. The registered enrollment target is 35 participants, below the 164-participant average among 6 other Varicose Veins trials with a reported enrollment target (79% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02462720, a Phase 4 study of Varicose Veins, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 4
Development phase
35 participants
Enrollment target
4
Study locations

Study Summary

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

Primary Outcome

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.

Conditions Studied

Interventions

  • DEVICE Radiofrequency ablation
  • DRUG Varithena®

Study Locations (4)

Florida

  • Coastal Vascular and Interventional, PLLC - Pensacola

Illinois

  • Midwest Institute for Minimally Invasive Therapies - Melrose Park

New York

  • Venous Institute of Buffalo - Amherst

Washington

  • Lake Washington Vascular - Bellevue

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2015-05
Est. Completion 2016-03
Phase Phase 4
Boston Scientific Corporation

280 total trials

What the finished NCT02462720 record still lists

NCT02462720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 164-participant average among 6 other Varicose Veins trials with a reported enrollment target (79% lower).

The record links to 1 condition, with Varicose Veins appearing as the primary indexed condition, and to 2 interventions - of which Radiofrequency ablation is the first listed.

NCT02462720 reports a single indexed study location in Florida, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT02462720 about?

NCT02462720 is a clinical study titled "COMFORT: A Multicenter, Open-label, Randomized, Crossover Study". The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.

What is the current status of trial NCT02462720?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2015-05. Estimated completion is 2016-03.

What conditions does trial NCT02462720 study?

This clinical trial studies the following conditions: Varicose Veins.

What interventions are being tested in trial NCT02462720?

The interventions under investigation include: Radiofrequency ablation (DEVICE), Varithena® (DRUG).

Who is sponsoring clinical trial NCT02462720?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02462720 being conducted?

This trial has 4 study locations across Florida, Illinois, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02462720, the US trial registry maintained by the National Library of Medicine. NCT02462720 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.