RecruitingNot Applicable

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

United States100 participantsStarted 2023-07-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0

Timeframe: Through 3 year follow-up

Trial details

NCT IDNCT05972343

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-07-31

Contact for this trial

Heather Garrett, M.D.

314-454-5206 hvgarrett@wustl.edu

View on ClinicalTrials.gov More Breast Cancer trials