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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: 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2004-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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.
Learn More About Clinical Trials
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
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