Recruiting

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

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.

ClinicalTrials.gov IDNCT05972343

PhaseNot Applicable

Enrollment100

SponsorWashington University School of Medicine

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Cancer of the Breast

About this study

Interventions

Device: Cryoablation — Takes place at single time point.

Primary outcomes

Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0 (Through 3 year follow-up)

Eligibility information

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.

Study locations

Washington University School of Medicine, St Louis, Missouri 63110 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.