NCT07629206 Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
| NCT ID | NCT07629206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IceCure Medical Ltd. |
| Condition | Low-Risk, Early Stage Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-07-17 |
| Primary Completion | 2034-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-07-17 with a primary completion date of 2034-07.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Provision of a signed and dated informed consent form. 2. Age ≥70 3. 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. 4. Lesions must be sonographically visible at the time of treatment 5. Clinically negative lymph node (N0). Exclusion Criteria: 1. Presence of lobular carcinoma. 2. Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%. 3. Evidence of lymphovascular invasion. 4. Presence of multifocal and/or multicentric breast cancer. 5. Presence of multifocal suspicious calcifications. 6. Presence of inflammatory features. 7. Previous ipsilateral breast radiation 8. Neoadjuvant endocrine treatment is provided to reduce the tumor size. 9. Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies. 10. Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. 11. Allergy to local anesthesia. 12. Any other reason defined as inoperable declared by a physician.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07629206 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Low-Risk, Early Stage 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 NCT07629206 currently recruiting?
Yes, NCT07629206 is actively recruiting participants. Contact the research team at eidanl@icecure-medical.com for enrollment information.
Where is the NCT07629206 trial being conducted?
This trial is being conducted at Glendale, United States, Germantown, United States.
Who is sponsoring the NCT07629206 clinical trial?
NCT07629206 is sponsored by IceCure Medical Ltd.. The trial plans to enroll 400 participants.
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