NCT03534258

Does Use of Rapid Response EEG Impact Clinical Decision Making

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Ceribell Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a prospective, non-randomized, observational, multicenter clinical trial. The primary aim of this study is to observe if the use of the rapid responds electroencephalography (EEG) system impacts physician decision making. Secondary aims include exploring the safety and performance information of the Ceribell EEG system compared to conventional EEG system. The study will recruit physicians (Faculty physicians and Trainees) at up to five institutions and examine the impact of rapid response EEG when providing care to patients in whom EEG recording has been ordered for clinical reasons.

Conditions

• Nonconvulsive Status Epilepticus
• Seizures

Interventions

Type	Name	Description
DEVICE	Ceribell Rapid Response EEG, Survey	This trial will qualitatively examine how information from rapid response and conventional EEG data changes physicians' diagnostic suspicion or their treatment decisions and confidence levels. In addition, the results will examine the mean time to EEG lead placement, and ease of use.

Timeline

• Start date: 2018-04-30
• Primary completion: 2019-04-30
• Completion: 2019-07-31
• First posted: 2018-05-23
• Last updated: 2019-08-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study