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

NCT02525913 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-10-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

RFA Applicator

Sponsors & Collaborators

  • Innoblative Designs, Inc.

    collaborator INDUSTRY

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Suzanne Klimberg, MD · University of Arkansas

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02525913 on ClinicalTrials.gov