NCT07494812

Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The intellidrop device is an FDA-approved system that automates safe, small volume of cerebral spinal fluid drainage with continuous pressure monitoring, reducing nursing workload and human error while improving patient mobility and comfort

Detailed description

The intellidrop (BrainSpace, Inc) was approved by the Food and Drug Administration (FDA) for use in automating CSF drainage while providing continuous intracranial pressure (ICP) monitoring. Control parameters can be programmed for requent removal of small volumes of fluid contingent on pressure remaining in target range, and with guardrails on volume drained over a range of timespans. This reduces the frequency and duration of nursing attention to managing the stopcock every four hours as in the current design and may reduce risk of human error. The compact and mobile design allows for more freedom for patient mobility, and importantly for patient satisfaction, there is no longer a need for the patient to lay supine for one out of every four hours because substantial (20mls) volumes of CSF are no longer removed.

Conditions

• NPH (Normal Pressure Hydrocephalus)

Interventions

Type	Name	Description
DEVICE	Intellidrop Automated CSF Drainage System	Participants will undergo lumbar drainage using the Intellidrop automated cerebrospinal fluid drainage system that monitors intracranial or spinal pressure and manages external drainage of cerebrospinal fluid and other body fluids to a user selected pressure target or volume target. Its closed loop, gravity-based drainage ensures natural flow, while offering position-agnostic precision control to achieve an hourly target volume. It connects to the distal end of the lumbar catheter outside the body and replaces the drainage collection device and manual nursing effort.
DEVICE	Intellidrop Automated CSF Drainage System	Participants will undergo lumbar drainage using the Intellidrop automated cerebrospinal fluid drainage system that provides continuous intracranial pressure monitoring and automated control of CSF removal. It is programmed to withdraw small frequent volumes of CSF within predefined safety limits reducing the need for manual stopcock adjustments and minimizing human error. It is designed to improve workflow efficiency, enhance patient mobility, and evaluate the device;s feasibility, performance and safety during the lumbar drain.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2026-03-27
• Last updated: 2026-03-31