Measurements of CSF Shunts and Off-Shunt Locations With W... | NCT06513572

Studies
Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices

NCT06513572

Sponsor

Rhaeos, Inc.

Status

Terminated

Last Update Posted

May 15, 2025Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Hydrocephalus

Interventions

FlowSense

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment

Expanded Access Info

Start Date

Jul 25, 2024Actual

Primary Completion Date

Jul 27, 2024Actual

Completion Date

Jul 27, 2024Actual

First Submitted Date

Jul 16, 2024

First Submission Date that Met QC Criteria

Jul 16, 2024

First Posted Date

Jul 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2025

Last Update Posted Date

May 15, 2025Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FlowSense	Device	This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

Measure	Description	Time Frame
Correlation of measurement data	Correlation between measurements from flowing shunts, non-flowing shunts, and off-shunt locations.	Approximately 1 hour

Eligibility Module

Eligibility Criteria

Inclusion criteria:

At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria:

Presence of an interfering open wound or edema in the FlowSense device measurement area
Patient-reported history of serious adverse skin reactions to silicone-based adhesives
Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals with at least one existing CSF shunt

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHOC Commerce Tower		Orange	California	92868	United States
Cedars-Sinai Accelerator

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases