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Evaluation of the NaviFUS System in Drug Resistant Epilepsy

StatusRecruiting
PhaseNot applicable
Started2023-10-02
View on ClinicalTrials.gov ↗
Participants with drug-resistant epilepsy (DRE) enrolled in this study will receive focused ultrasound (FUS) treatment with the NaviFUS System, guided by the neuronavigation system to evaluate the safety and efficacy of using NaviFUS System. During the treatment, the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi. The study consists of a 60-day screening period for baseline observation prior to treatment, a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System, and a safety follow-up period of 81 days.

Amendment history 2 changes detected by DataLookout

2026-09-11
Primary completion pushed: 2026-07-01 → 2027-06-01
2026-09-11
Completion pushed: 2026-07-01 → 2027-06-01
Trial Details
NCT Number NCT05947656
Lead Sponsor Genovate-NaviFUS (Australia) Pty Ltd.
Collaborators: Genovate Biotechnology Co., Ltd.,, NaviFUS Corporation
Conditions Epilepsy, Temporal Lobe, Drug Resistant Epilepsy
Enrollment 18 participants
Start Date 2023-10-02
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-10