ExAblate MRgFUS / Breast Cancer · Interventional Study

Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed clinical trial registry record documenting a single-arm, non-randomized evaluation of MR-guided focused ultrasound (ExAblate MRgFUS) in early breast cancer. No outcome results are posted in this registry entry; only the planned primary outcome (incidence and severity of adverse events over 5 years) is stated.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Breast Cancer; Female; age from 18 Years. Intervention: Treatment Arm. n = 91. 1 site: Japan.

Key findings

Safety

No effect size, adverse event rates, efficacy measures, or statistical analysis reported.

Who this may help

This record confirms that a device trial in early breast cancer has completed enrollment and follow-up, but clinicians and researchers cannot assess safety or effectiveness until results are published. The absence of posted outcomes limits any clinical inference at this time.

Plain-language summary

Registry record of a completed single-arm, non-randomized device study with no results posted; design and enrollment are documented but outcomes remain unreported.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Incidence and severity of Adverse events (assessed at 5 years)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationBreast Cancer; Female; age from 18 Years

Sample size91

InterventionTreatment Arm

Setting1 site: Japan

Reported figures

Quoted from the source exactly as published.

Planned enrollment91

Study phaseNA

Primary outcome measureIncidence and severity of adverse events, 5 years

Recruitment statusCOMPLETED

Clinical bottom line

Caveats

No results posted; outcome data not available in this registry entry.
Single-arm, non-randomized design without a control or comparator group.
No effect size, adverse event rates, efficacy measures, or statistical analysis reported.
5-year follow-up data collection may still be ongoing; completion date not stated.

Evidence assessment

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.

Study design

limited

Single-arm, non-randomized design; no comparator or control group.

Directness

strong

Clinical study in early breast carcinoma patients; addresses the stated condition directly.

Consistency

insufficient

Single study; no comparison with other trials or data reported.

Risk of bias

limited

Non-randomized, single-arm design introduces selection bias; no blinding mentioned.

Sample adequacy

moderate

91 participants enrolled; adequate for a device feasibility study but modest for effectiveness.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT02794558). This is a study registration, not published results. Lead sponsor: InSightec. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 91 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DEVICE: ExAblate MRgFUS. Primary outcome measures: Incidence and severity of Adverse events , 5 years. Brief summary: Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

InSightecNCT02794558ExAblate MRgFUSBreast Cancer