Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation (eRFA)
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|ClinicalTrials.gov Identifier: NCT00571987|
Recruitment Status : Completed
First Posted : December 12, 2007
Results First Posted : October 6, 2015
Last Update Posted : November 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Breast||Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||December 2013|
This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).
Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)
Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
- Number of Patients Requiring 2nd Surgery for Close or Positive Margins [ Time Frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery ]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.
- Recurrence of Breast Cancer at Prior Site of Disease [ Time Frame: Until study end (2 years) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571987
|United States, Arkansas|
|University of Arkansas For Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||V. Suzanne Klimberg, M.D.||University of Arkansas|