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

Conditions

• NPH (Normal Pressure Hydrocephalus)

Eligibility Criteria

Sex

ALL

Age

60 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Intellidrop Automated CSF Drainage System — DEVICE
  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.
• Intellidrop Automated CSF Drainage System — DEVICE
  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.

Study Details

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 Dates

Start date

May 14, 2026

Status verified

May 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Experimental - Intellidrop Automated CSF Drainage System
  Device

Primary Outcome Measure

Feasibility [ Time Frame: FIM scores will be obtained on a daily basis during month 3 - 5. ]

Central Contacts

• Padraig O'Suilleabhain, M.D.
  214-648-2943
  [email protected]
• Maria Denbow, CCRP
  214-648-6719
  [email protected]

Locations (1)

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