COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
Recruiting · NCT05972343 · Observational (researchers observe without assigning treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Cryoablation
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Eligibility criteria (as published)
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.
Where it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States