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VenaSeal Sapheon Closure System Pivotal Study (VeClose)

NCT01807585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2018-06-26

Study results available
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Summary

The VeClose pivotal study was a controlled, randomized, prospective, multicenter, pivotal study in which patients with venous reflux in the great saphenous vein (GSV) were treated with either the VenaSeal closure system (VenaSeal SCS) or radiofrequency ablation (RFA) therapy.

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.

Sponsors & Collaborators

  • Sapheon, Inc.

    collaborator INDUSTRY

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Nick Morrison, MD · Morrison Vein Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-12-31
Completion
2017-04-10

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 NCT01807585 on ClinicalTrials.gov