NCT05972343 COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
| NCT ID | NCT05972343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-07-26 |
| Primary Completion | 2031-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-07-26 with a primary completion date of 2031-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Heather Garrett, M.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05972343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05972343 currently recruiting?
Yes, NCT05972343 is actively recruiting participants. Contact the research team at hvgarrett@wustl.edu for enrollment information.
Where is the NCT05972343 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05972343 clinical trial?
NCT05972343 is sponsored by Washington University School of Medicine. The principal investigator is Heather Garrett, M.D. at Washington University School of Medicine. The trial plans to enroll 100 participants.
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