Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)

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-r

Trial Details

NCT ID
NCT07629206
Phase
NA
Sponsor
IceCure Medical Ltd.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Cryoablation
Locations (sample)
  • Glendale, California, United States|34.14251,-118.25508
  • Germantown, Tennessee, United States|35.08676,-89.81009

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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