ArticleStereotactic and functional neurosurgery2026
Initial Clinical Experience with the First FDA-Approved sEEG-Guided Radiofrequency Ablation System Featuring Real-Time Temperature Monitoring: A Case Series.
Article in Stereotactic and functional neurosurgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07546253 (OneRF® Ablation System Post-Market Real-World Evidence Registry), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
OneRF® Ablation System Post-Market Real-World Evidence Registry
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8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionStereoelectroencephalography-guided radiofrequency ablation (sEEG-RFA) has been used to create stereotactic lesions in epileptic networks. The method has been applied as a diagnostic (and at times, palliative) intervention, primarily in European epilepsy programs. To date, the technique has not been widely popularized in the USA given the lack of FDA-approved technology permitting safe usage of in situ sEEG electrodes for this purpose. Recently, the FDA approved a new hollow sEEG electrode and OneRF generator (NeuroOne) featuring real-time thermal monitoring. CASE PRESENTATIONS: The authors present four illustrative, consecutive cases of refractory epilepsy patients undergoing sEEG, who underwent subsequent sEEG-RFA using the new technology. The procedure was diagnostic in all cases, with no adverse events. Importantly, all 4 patients reported decreased seizure burden following the procedure, with observed improvements informing subsequent surgical decision-making in 3 patients.
conclusionA new FDA-approved, hollow sEEG electrode technology permits safe sEEG-RFA lesioning, with a positive experience for both the patient and clinical team. The authors reaffirm use of this strategic technique as a diagnostic and prognostic tool, with possibility of secondary therapeutic, ablative effects. This development represents a significant advancement in the work-up of patients with intractable epilepsy, who are undergoing sEEG for invasive evaluation.
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