Clinical trials for efficacy and safety for a novel device intermediating traditional needle electrodes to BIS-VISTA system for frontal neurosurgical procedure

Clinical trials for efficacy and safety for a novel device intermediating traditional needle electrodes to BIS-VISTA system for frontal neurosurgical procedure - Intermediating deice trial for BIS VISTA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031217

Enrollment

Registered

2018-02-09

Start date

2018-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia cases management with processed EEG monitoring

Interventions

BIS related values detected between standard BIS sensor and needle electrodes connected with new device during general anesthesia. BIS related values detected between standard BIS sensor and needle el

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ASA classification 1-2 Patients consented to participate in this study

Exclusion criteria

Exclusion criteria: Altered levels of consciousness before the surgery due to intracranial disorders,neurological disorders,psychiatric disorders;pathergy test positive;metal hypersensitivity.

Design outcomes

Primary

Measure	Time frame
EEG wave, BIS related Values, EMG	—

Secondary

Measure	Time frame
Damages at the needle penetration area	—

Countries

Japan

Contacts

Public ContactHideki Harada

Kurume University School of Medicine Department of Anesthesiology

hidehara@med.kurume-u.ac.jp0942353311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026