Recruiting

Observational Study

Sponsor:

Baylor College of Medicine

Code:

NCT05546996

Conditions

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

FlowSense

Study Details

Brief summary:

Rhaeos, Inc. is initially targeting hydrocephalus, a life threatening condition caused by an abnormal accumulation of cerebrospinal fluid (CSF). Implantable shunts, the gold standard treatment, often fail, leading to multiple trips to the emergency room and repeat surgeries. There is no technology available today that can easily assess CSF flow in shunts wirelessly, bedside, and without capital equipment until now.

FlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of CSF. Similar in size to a bandage, it is composed of soft, silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app. With FlowSense, monitoring of shunt function can occur in clinics, in-patient settings, and emergency departments, thereby reducing unnecessary imaging, hospital length of stay, and readmission costs.

Conditions

Hydrocephalus

Study ID

NCT05546996

Start date

Jul 11, 2023

Status verified date

Mar, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with one or more existing external ventricular drains (EVDs).

Exclusion Criteria:

  • Patients with no external ventricular drains (EVDs).

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Phase A:

Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system.

other: Phase B

Exploratory study to generate initial data on the correlation between FlowSense flow rate measurements (FlowSense Flow Rate) and: A) EVD drainage data, quantified via video recording; B) intracranial pressure (ICP) measurements

Interventions

FlowSense

Patients will have one or more existing external ventricular drains (EVDs). Phase B patients will additionally have an accessible (shaved) region of skin >3 cm x 3 cm overlaying the EVD tubing.

Clinical data to be collected include: 1) total drainage volume1 over the 20-minute measurement period; 2) handheld ultrasound measurement of skin thickness2 over the EVD; and 3) an ICP waveform from a standard-of-care transducer, 4) dimensions (inner diameter and outer diameter) of tunneled catheter. Single patients may be measured multiple times during their admission; each measurement will be considered independent for analysis.

Primary outcome measure

  • Exploratory outcome [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Samuel McClugage, MD

8328223950mcclugag@bcm.edu

Sarah Martinez

8328223950sxwisor@texaschildrens.org

Locations

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Sarah Martinez, MPH

sxwisor@texaschildrens.org

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • EVD shunt
  • Hydrocephalus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-03-25.