Recruiting

Intellidrop Device

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07494812

Conditions

NPH (Normal Pressure Hydrocephalus)

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Intellidrop Automated CSF Drainage System

Intellidrop Automated CSF Drainage System

Study Details

Brief 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

Conditions

NPH (Normal Pressure Hydrocephalus)

Study ID

NCT07494812

Start date

May 14, 2026

Status verified date

May, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients will be adults aged 60 years or older with suspected iNPH who are being admitted to the hospital for the purpose of an LDT specifically to evaluate for benefit from shunt placement.

Exclusion Criteria:

  • Patients who are under 18 years of age, pregnant, or are currently incarcerated will be excluded from participating in this study.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Experimental - Intellidrop Automated CSF Drainage System

Device

Interventions

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.

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.

Primary outcome measure

  • Feasibility [ Time Frame: FIM scores will be obtained on a daily basis during month 3 - 5. ]
  • Acceptability [ Time Frame: from enrollment to the end of three months or until 10 subjects have been enrolled ]

Central Contacts and Locations

Central contacts

Padraig O'Suilleabhain, M.D.

214-648-2943padraig.osuilleabhain@utsouthwestern.edu

Maria Denbow, CCRP

214-648-6719maria.denbow@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Maria Denbow

281-605-0356Maria.Denbow@UTSouthwestern.edu

Principal Investigator:

Padraig O'Suilleabhain, M.D.

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • UPGRADE
  • Cerebrospinal fluid buildup (CSF buildup)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-02.