An interventional study of Cryoablation in Low-Risk, Early Stage Breast Cancer, sponsored by IceCure Medical Ltd.. Recruiting at 2 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by IceCure Medical Ltd. · Not applicable, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 400 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →IceCure Medical Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria:
Exclusion Criteria:
FDA-Approved cryoablation procedure for the indicated population
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.
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate
The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
Time frame: 5 Years
Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate
The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.
Time frame: 5 Years
Complete Primary Tumor Ablation Rate
The percentage of patients with complete tumor ablation, defined by adequate iceball coverage of the target tumor during the cryoablation procedure and absence of residual tumor at the 6-month follow-up.
Time frame: 6 Months
Procedure duration (minutes)
Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes
Time frame: The day of the procedure
Number of hospitalization days following the procedure
Length of post-procedural hospitalization (If needed), measured as the number of days from the procedure until hospital discharge.
Time frame: 6 Months
Days to resume normal activity
Number of days after cryoablation until return to routine daily activities, as reported by the patient.
Time frame: 6 Months
Number of procedure-related outpatient visits
Number of procedure-related outpatient visits post the procedure, which are unplanned in the study schedule of activities
Time frame: 6 Months
Physician's satisfaction with the breast's cosmetic results
Assessed using the Sneeuw Questionnaire, an observer-rated assessment of cosmetic changes following treatment. Items are scored on a 4-point scale ranging from 1 (None) to 4 (Severe), with the overall cosmetic result rated from 1 (Poor) to 4 (Excellent).
Time frame: 6 Months
Non-serious adverse events (related/non-related to device and procedure) and procedure-related complications.
Number, nature, and percentage of patients with non-serious adverse events (related/nonrelated to device and procedure) and procedure-related complications up to 6 months.
Time frame: 6 Months
Local recurrence and Second primary breast cancer rates
The percentage of patients with local breast cancer recurrence or second primary breast cancer.
Time frame: 5 Years
Patient's satisfaction with cosmetic outcomes
Patients' satisfaction will be assessed at 6-month follow-up and subsequent visits through 5 years using the 'Satisfaction with Breasts' scale from the BREAST-Q 2.0 Patient-Reported Outcome (PRO) Breast-Conserving Surgery module. Scores are reported on a 0 (Worst) to 100 (Best) scale.
Time frame: 5 Years
Patients' Quality of life (QoL)
Improvement or maintenance of patient's quality of life will be evaluated at 6-month follow-up and subsequent visits through 5 years, compared to baseline, using two scales from the BREAST-Q 2.0 PRO Breast-Conserving Surgery module: Physical Well-Being: Chest, and Psychosocial Well-Being. BREAST-Q has domain scores reported on a 0 (Worst) to 100 (Best) scale.
Time frame: 5 Years
Locoregional recurrence (LRR) rate
The percentage of patients who develop locoregional recurrence within 5 years post-procedure.
Time frame: 5 Years
Disease-Free Survival (DFS) rate
The percentage of patients without evidence of IBTR, regional, or distant breast cancer recurrence, contralateral breast cancer, or death due to breast cancer.
Time frame: 5 Years
Overall Survival (OS) rate
The percentage of participants who did not experience death due to any cause up to 5 years.
Time frame: 5 Years
Breast cancer survival rate
The percentage of patients who did not experience death due to breast cancer up to 5 years.
Time frame: 5 Years
Rate of discontinuation of routine follow-up procedures
The percentage of patients who discontinue routine breast-related follow-up procedures.
Time frame: 5 Years
Serious adverse events (related/non-related to device and procedure).
The number, nature, and percentage of patients experiencing serious adverse events (SAEs), related and non-related to the device and procedure.
Time frame: 5 Years
Plan to share: No
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IceCure Medical Ltd.