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NCT05015751

Assessment of CSF Shunt Flow With Thermal Measurements A

Completed Results posted Last updated 19 December 2024
What this trial tests

trial testing Thermal Anisotropy Measurement Device in Hydrocephalus in 44 participants. Completed in 13 July 2022.

Timeline
25 August 2021
Primary endpoint
13 July 2022
13 July 2022

Quick facts

Lead sponsorRhaeos, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment44
Start date25 August 2021
Primary completion13 July 2022
Estimated completion13 July 2022
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rhaeos, Inc. — full company profile →

Who can join

Eligibility, any sex, with Hydrocephalus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study Device Sensitivity Primary · 14-day follow-up period

Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.

GroupValue95% CI
Hydrocephalus Patients88
Study Device Specificity Primary · 14-day follow-up period

Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.

GroupValue95% CI
Hydrocephalus Patients87

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Thermal Anisotropy Measurement Device

Trials testing the same drug.

Other recruiting trials for Hydrocephalus

Currently open trials in the same condition.

Other Rhaeos, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05015751.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing