Assessment of CSF Shunt Flow With Thermal Measurements B

Completed

• Conditions: Hydrocephalus
• Interventions: Device: Thermal Anisotropy Measurement Device

• Registration Number: NCT05432986
• Lead Sponsor: Rhaeos, Inc.

Brief Summary

This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

Detailed Description

Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-27
• Study Start: 2022-07-07
• Primary Completion: 2023-11-03
• Study Completion: 2023-11-10
• Results First Submitted: 2024-12-19
• Results First Submitted QC: 2024-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Results First Posted: 2025-01-30
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hydrocephalus Patients	Thermal Anisotropy Measurement Device	Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.

Primary Outcome Measures

Name	Time	Method
Study Device Sensitivity	7-day follow-up period	Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.
Study Device Specificity	7-day follow-up period	Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.

Trial Locations

Locations (9)

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States

Dayton Children's Hospital; 🇺🇸 Dayton, Ohio, United States

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States