NCT05972343Recruiting
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
Washington University School of Medicine
Start Date
7/26/2023
Completion Date
7/31/2031
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
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
Cryoablation
Conditions
Breast CancerCancer of the Breast
Locations
Washington University School of Medicine
St Louis, Missouri 63110
United States