Formative Usability Assessment of Wireless Thermal Anisot... | NCT06040697

Studies
Formative Usability Assessment of Wireless Thermal Anisotropy Devices

NCT06040697

Sponsor

Rhaeos, Inc.

Status

Recruiting

Last Update Posted

May 15, 2025Actual

Enrollment

145Estimated

Phase

Not provided

Conditions

Hydrocephalus

Interventions

Thermal Anisotropy

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

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2023Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Sep 8, 2023

First Posted Date

Sep 15, 2023Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.

Detailed Description

Not provided

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

145Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usability Assessment Cohort		No interventions administered. Device usability assessment only.	Device: Thermal Anisotropy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thermal Anisotropy	Device	Usability assessment observation.	Usability Assessment Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exploratory device usability feedback	Identification of usability risks [unscored]	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
Subject or caregiver can clearly communicate and document information in English
Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
Subject is at least 5 years old but not more than 80 years old

Exclusion Criteria:

Presence of an interfering open wound in the device application region
Subject-reported history of adverse skin reactions to adhesives

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with an existing Cerebrospinal Fluid (CSF) shunt

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Somera	Contact	855-814-3569		info@rhaeos.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhaeos, Inc.	Recruiting	Chicago	Illinois	60654	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006849	Hydrocephalus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided