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

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

Plain Language Summary

Simplified for easier understanding

This study (COOL-IT-PRO) is investigating the use of cryoablation — a procedure that uses extreme cold to destroy cancer tissue — as a treatment for breast cancer in patients who are not able to have or have chosen not to have surgery. Cryoablation is guided by ultrasound and done without general anesthesia, making it an option for people for whom traditional surgery is not suitable. The study aims to assess how well this approach controls the cancer. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with breast cancer - Your tumor is visible on ultrasound and is more than 5mm from the skin surface - You are not undergoing surgery for one of the following reasons: you have a medical condition that makes sedation or anesthesia unsafe, your disease is unresectable or metastatic, your doctor has determined surgery is not indicated for another reason, or you have personally declined surgery - You are willing to sign informed consent **You may NOT be eligible if...** - You are able to have surgery and have not declined it - Your tumor cannot be seen clearly on ultrasound or is too close to the skin - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECryoablation

Takes place at single time point.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05972343


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