RecruitingNCT05972343

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

COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry

Sponsor

Washington University School of Medicine

Enrollment

100 participants

Start Date

Jul 26, 2023

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Cancer of the Breast

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

Min Age: 18 Years

Inclusion Criteria10

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.