SeCure Endovenous Laser Treatment Study (SeCure)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02215369|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Venous Insufficiency||Device: VenaCure EVLT 400 µm fiber Procedure Kit||Not Applicable|
This is a single-arm, prospective, multicenter, non-blinded clinical trial. Study data will be summarized and submitted to the FDA in a premarket notification once all treated subjects have completed the 3 month visit. Longer term followup is being performed for publication purposes.
Patients diagnosed with incompetent Perforator Veins (IPV's) and meet all inclusion and none of the exclusion criteria will be eligible for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: VenaCure EVLT 400 µm fiber Procedure Kit
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
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.
- Acute Primary Ablation Success [ Time Frame: 10 day ]The primary effectiveness endpoint is "Acute Primary Ablation Success" defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.
- Technical Success [ Time Frame: Treatment ]Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.
- Safety [ Time Frame: Duration of the study ]Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE), and unanticipated adverse device effects (UADE) will be followed. Device malfunctions will be reported by the investigator and reviewed by the Sponsor in compliance with applicable regulations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215369
|United States, Illinois|
|Midwest Institute for Minimally Invasive Therapies|
|Melrose Park, Illinois, United States, 60160|
|Vein Clinics of America|
|Orland Park, Illinois, United States, 60462|
|United States, New Jersey|
|Englewood Hospital and Medical Center|
|Englewood, New Jersey, United States, 07631|
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Virginia|
|The Vein Center of Virginia|
|Norfolk, Virginia, United States, 23507|
|United States, Washington|
|Lake Washington Vascular|
|Bellevue, Washington, United States, 98004|