Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 1 study, sponsored by University of Arkansas.

NCT00571987 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.

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
University of Arkansas

318 total trials

What the finished NCT00571987 record still lists

NCT00571987 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00571987's enrollment target sits among peer trials

107 531st of 2000 higher than 1,470 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05491668 · 107 participants

    Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

  • NCT06041594 · 107 participants · NA

    Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

  • NCT06081426 · 107 participants · NA

    Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

  • NCT06527599 · 107 participants · NA

    Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00571987, the US trial registry maintained by the National Library of Medicine. NCT00571987 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.