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NCT00571987 · ClinicalTrials.gov registry record · Phase 1

Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

A Phase 1 study, sponsored by University of Arkansas.

Completed
Registry status
Phase 1
Development phase
107
Enrollment target

NCT00571987 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 107 participants.

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The verdict

NCT00571987, a Phase 1 study, has completed, sponsored by University of Arkansas.

COMPLETED
Registry status
Phase 1
Development phase
107 participants
Enrollment target

Study Summary

In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.

Interventions

  • DEVICE AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2004-09
Est. Completion 2013-12
Phase Phase 1

Sponsor

University of Arkansas

318 total trials

What the Registry Record Tells You About NCT00571987

The ClinicalTrials.gov registry entry for NCT00571987 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe) is the first listed.

NCT00571987 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00571987 about?

NCT00571987 is a clinical study titled "Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation". In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This...

What is the current status of trial NCT00571987?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2004-09. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00571987?

The interventions under investigation include: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe) (DEVICE).

Who is sponsoring clinical trial NCT00571987?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

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

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, or report a data error.