Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue



Status:Withdrawn
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2015
End Date:September 2016

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The purpose of this study is to build a device that will consistently ablate (destroy or
remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the
tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to
handle, perform the ablation in less time and by so ablating this margin would avoid the
need in many for reoperation to obtain negative margins and based on preliminary data avoid
the need for radiation. This would be especially important in poor and rural patients and
would lead to decreased costs of treatment in patients with favorable breast cancer.


Inclusion Criteria:

- Female

- Age greater than or equal to 18 years.

- Receiving bi-lateral mastectomy due to tumor in the breast, or by choice
(prophylactic mastectomy). Only non-cancerous breast tissue will be included in the
study.

- Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

- Those determined by the study investigator to have mental, physical, or medical
conditions that would indicate that they should not participate.

- Because there is no patient contact with the device no medical contraindications are
foreseen.
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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mi
from
Little Rock, AR
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