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NOT YET RECRUITING
NCT07494812
NA

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

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

60 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-03-15

Completion Date

2026-10-31

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

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.