VenaSeal Sapheon Closure System Pivotal Study (VeClose)

NACompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

December 31, 2013

Study Completion Date

April 10, 2017

Conditions
Great Saphenous Vein (GSV) With Venous Reflux Disease
Interventions
DEVICE

VenaSeal SCS

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

DEVICE

ClosureFast Radiofrequency Ablation (RFA)

Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.

DEVICE

Roll-in (VenaSeal SCS)

Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.

Trial Locations (10)

14120

Vein Institute of Buffalo, North Tonawanda

21030

MD Laser Skin & Vein Institute, Hunt Valley

23452

Sentara Vascular Specialist, Virginia Beach

60181

Vein Clinics of America, Oakbrook Terrace

62701

Prairie Education & Research Cooperative, Springfield

80111

Radiology Imaging Associates (RIA), Greenwood Village

85255

Morrison Vein Institute, Scottsdale

92121

GBK Cosmetic Laser Dermatology, San Diego

97701

Inovia Vein Specialty Center, Bend

98004-4623

Lake Washington Vascular, Bellevue

Sponsors
All Listed Sponsors
collaborator

Sapheon, Inc.

INDUSTRY

lead

Medtronic Endovascular

INDUSTRY

NCT01807585 - VenaSeal Sapheon Closure System Pivotal Study (VeClose) | Biotech Hunter | Biotech Hunter