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Recruiting NCT05972343

COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients

Trial Parameters

Condition Breast Cancer
Sponsor Washington University School of Medicine
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-26
Completion 2031-07-31
Interventions
Cryoablation

Brief Summary

This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.

Eligibility Criteria

Eligibility Criteria: * Diagnosis of breast cancer. * Mass must be visible on ultrasound and \> 5 mm from skin. * Not undergoing surgery, because: * Patient has a medical condition that would not allow sedation or general anesthesia * Surgery is not clinically indicated due to unresectable and/or metastatic disease * Surgery is not clinically indicated for another reason * Patient declines surgery * At least 18 years old. * Able to understand and willing to sign an IRB-approved written informed consent document.

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