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SeCure Endovenous Laser Treatment Study

NCT02215369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-05-19

Study results available
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Summary

The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins. AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of IPVs.

Conditions

  • Chronic Venous Insufficiency

Interventions

DEVICE

VenaCure EVLT 400 µm fiber Procedure Kit

The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.

Sponsors & Collaborators

  • Angiodynamics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-03-31
Completion
2019-01-14

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 NCT02215369 on ClinicalTrials.gov