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ExAblate MRgFUS / Breast Cancer · Phase 2 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 2 registry record describing a planned prospective, non-randomized, single-arm study of MR-guided focused ultrasound (ExAblate MRgFUS) for breast cancer ablation. No results are posted in this registry entry; it documents enrollment of 14 participants and planned assessment of safety and histopathological response at 5 weeks post-treatment.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Breast Cancer; Female; age from 18 Years. Intervention: ExAblate. n = 14. 1 site: Germany.
This is a completed Phase 2 registry record describing a planned prospective, non-randomized, single-arm study of MR-guided focused ultrasound (ExAblate MRgFUS) for breast cancer ablation. No results are posted in this registry entry; it documents enrollment of 14 participants and planned assessment of safety and histopathological response at 5 weeks post-treatment.
Single-arm, non-randomized design precludes definitive safety or efficacy claims
This registry record documents a completed Phase 2 study but provides no outcome data. Clinicians and researchers should await publication of results to evaluate the safety profile and ablation effectiveness of MR-guided focused ultrasound in breast cancer.
Phase 2, single-arm, non-randomized registry record with no results posted; describes planned safety and histopathological assessment in a small cohort without comparator or outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This registry record documents a completed Phase 2 study but provides no outcome data. Clinicians and researchers should await publication of results to evaluate the safety profile and ablation effectiveness of MR-guided focused ultrasound in breast cancer.
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 (NCT01620359). This is a study registration, not published results. Lead sponsor: InSightec. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 14 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DEVICE: ExAblate MRgFUS. Primary outcome measures: Adverse Events , 5 weeks post treatment; Histopathological analyses , 5 weeks post treatment. Brief summary: The goal of this prospective, non-randomized, single-arm, multi site, international study is to develop data to evaluate the safety and effectiveness of the ExAblate MRgFUS system in the ablation of breast cancer and of MRI. The goal of MRgFUS ablation of breast cancer is to plan and ablate the entire tumor volume in a treatable and device accessible location.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.