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NCT01807585 · ClinicalTrials.gov registry record · NA

VenaSeal Sapheon Closure System Pivotal Study (VeClose)

A NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease, sponsored by Medtronic Endovascular.

Completed
Registry status
NA
Development phase
242
Enrollment target
10
Study locations

NCT01807585: Completed NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease, sponsored by Medtronic Endovascular.

NCT01807585 is a NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease that has completed, run by Medtronic Endovascular. The registered enrollment target is 242 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01807585, a NA study of Great Saphenous Vein (GSV) With Venous Reflux Disease, has completed, sponsored by Medtronic Endovascular.

COMPLETED
Registry status
NA
Development phase
242 participants
Enrollment target
10
Study locations

Study 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.

Interventions

  • DEVICE VenaSeal SCS
  • DEVICE ClosureFast Radiofrequency Ablation (RFA)
  • DEVICE Roll-in (VenaSeal SCS)

Study Locations (10)

Illinois

  • Vein Clinics of America - Oakbrook Terrace
  • Prairie Education & Research Cooperative - Springfield

Arizona

  • Morrison Vein Institute - Scottsdale

California

  • GBK Cosmetic Laser Dermatology - San Diego

Colorado

  • Radiology Imaging Associates (RIA) - Greenwood Village

Maryland

  • MD Laser Skin & Vein Institute - Hunt Valley

New York

  • Vein Institute of Buffalo - North Tonawanda

Oregon

  • Inovia Vein Specialty Center - Bend

Virginia

  • Sentara Vascular Specialist - Virginia Beach

Trial Details

FieldValue
Enrollment Target 242 participants
Start Date 2013-03
Est. Completion 2017-04-10
Phase NA

Sponsor

Medtronic Endovascular

25 total trials

What the Registry Record Tells You About NCT01807585

The ClinicalTrials.gov registry entry for NCT01807585 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). The listed sponsor is Medtronic Endovascular, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Great Saphenous Vein (GSV) With Venous Reflux Disease appearing as the primary indexed condition, and to 3 interventions - of which VenaSeal SCS is the first listed.

NCT01807585 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Illinois, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT01807585 about?

NCT01807585 is a clinical study titled "VenaSeal Sapheon Closure System Pivotal Study (VeClose)". 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.

What is the current status of trial NCT01807585?

This trial is currently completed. It is a NA study. The enrollment target is 242 participants. The study started on 2013-03. Estimated completion is 2017-04-10.

What conditions does trial NCT01807585 study?

This clinical trial studies the following conditions: Great Saphenous Vein (GSV) With Venous Reflux Disease.

What interventions are being tested in trial NCT01807585?

The interventions under investigation include: VenaSeal SCS (DEVICE), ClosureFast Radiofrequency Ablation (RFA) (DEVICE), Roll-in (VenaSeal SCS) (DEVICE).

Who is sponsoring clinical trial NCT01807585?

This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01807585 being conducted?

This trial has 10 study locations across Arizona, California, Colorado, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.