NCT07629206 · IceCure Medical Ltd.
Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
What this study is about
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy. This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care.
View original scientific description
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy. This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment. In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.
Interventions
DEVICE
Cryoablation
Cryoablation procedure, without resection, using the IceCure Medical ProSense® Cryoablation System. Patients will be also provided with adjuvant endocrine therapy for 5 years post-treatment. The IceCure ProSense® cryoablation system is intended for cryogenic destruction of tissue by the application of extreme cold temperatures.
Primary outcome measures
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
Time frame: 5 Years
The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate
Time frame: 5 Years
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of a signed and dated informed consent form.
- Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria:
- Unifocal primary disease
- Tumor size ≤1.5 cm in greatest diameter
- Estrogen receptor positive, Progesterone receptor positive, and HER2 negative
- Low-risk tumor biology, defined as Ki67\<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail.
- Lesions must be sonographically visible at the time of treatment
- Clinically negative lymph node (N0).
Exclusion criteria
- Presence of lobular carcinoma.
- Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%.
- Evidence of lymphovascular invasion.
- Presence of multifocal and/or multicentric breast cancer.
- Presence of multifocal suspicious calcifications.
- Presence of inflammatory features.
- Previous ipsilateral breast radiation
- Neoadjuvant endocrine treatment is provided to reduce the tumor size.
- Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies.
- Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
- Allergy to local anesthesia.
- Any other reason defined as inoperable declared by a physician.
Where
- Glendale, California
- Germantown, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2026 · Source of record for eligibility and locations