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Low Risk, Early Stage Breast Cancer / Cryoablation · Interventional Study
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered post-marketing observational study of cryoablation for early-stage low-risk breast cancer in patients aged ≥70 years. No results are yet available in this registry record; the study is actively recruiting and designed to track ipsilateral breast tumor recurrence and other outcomes over 5 years.
Interventional, Single Group, Open label, Treatment purpose. Low-Risk, Early Stage Breast Cancer; age from 70 Years. Intervention: Low-risk, Early satge breast cancer. n = 400. 2 sites: United States.
This is a registered post-marketing observational study of cryoablation for early-stage low-risk breast cancer in patients aged ≥70 years. No results are yet available in this registry record; the study is actively recruiting and designed to track ipsilateral breast tumor recurrence and other outcomes over 5 years.
No interim or final efficacy or safety results are provided in this source.
Results are not yet available. When data mature, this post-market study will provide real-world effectiveness and safety data on cryoablation; however, lack of a comparator limits ability to assess superiority or non-inferiority versus standard care.
This is a post-marketing registry study with no results yet reported; it is designed to collect safety and effectiveness data prospectively but carries no outcome data to assess.
As stated by the source record.
Quoted from the source exactly as published.
Results are not yet available. When data mature, this post-market study will provide real-world effectiveness and safety data on cryoablation; however, lack of a comparator limits ability to assess superiority or non-inferiority versus standard care.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07629206). This is a study registration, not published results. Lead sponsor: IceCure Medical Ltd.. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Low-Risk, Early Stage Breast Cancer. Interventions: DEVICE: Cryoablation. Primary outcome measures: Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate , 5 Years; Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate , 5 Years. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.