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COMPLETED NA

VenaSeal Sapheon Closure System Pivotal Study (VeClose)

NCT01807585 · View on ClinicalTrials.gov ↗

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

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01807585

The ClinicalTrials.gov registry entry for NCT01807585 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Endovascular, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01807585 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Illinois, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01807585?

This trial is sponsored by Medtronic Endovascular, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial