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Trial record 8 of 13 for:    klimberg and phase II

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

This study has been completed.
Sponsor:
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00571987
First received: December 11, 2007
Last updated: October 28, 2015
Last verified: October 2015
Results First Received: July 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer of the Breast
Intervention: Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was consented to the study in September 2004. The final subject was consented in March 2010. A total of 107 subjects were consented.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As part of this non-blinded and non-randomized study all participants receive ablation.

Reporting Groups
  Description
Subjects Received RFA Treatment 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.

Participant Flow:   Overall Study
    Subjects Received RFA Treatment
STARTED   107 
COMPLETED   100 
NOT COMPLETED   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RFA Treatment 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.

Baseline Measures
   RFA Treatment 
Overall Participants Analyzed 
[Units: Participants]
 107 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.02  (10) 
Gender 
[Units: Participants]
 
Female   107 
Male   0 


  Outcome Measures
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1.  Primary:   Number of Patients Requiring 2nd Surgery for Close or Positive Margins   [ Time Frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery ]

2.  Secondary:   Recurrence of Breast Cancer at Prior Site of Disease   [ Time Frame: Until study end (2 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Suzanne Klimberg
Organization: UAMS
phone: 501-686-6504
e-mail: klimbergsuzanne@uams.edu


Publications:

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00571987     History of Changes
Other Study ID Numbers: UAMS 29143
Study First Received: December 11, 2007
Results First Received: July 29, 2015
Last Updated: October 28, 2015
Health Authority: United States: Institutional Review Board