Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-24

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients

NCT01323764

Hydrocephalus

COMPLETED PHASE4

ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

NCT04309383

Pseudotumor Cerebri

UNKNOWN

Physician Preference Study of ShuntCheck - Madsen

NCT00583336

CSF Flow Through the Shunt of a Hydrocephalus Patient

UNKNOWN NA

Qualitative Radionuclide Shuntography for Adult Patients With Suspected V-P Shunt Malfunction

NCT02894216

Ventriculoperitoneal Shunt Malfunction Radionuclide Shuntography

COMPLETED

ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

NCT01881711

Suspected CSF Shunt Obstruction

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hydrocephalus, Normal Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ShuntCheck

Participants will be administered the ShuntCheck diagnostic test.

ShuntCheck

Intervention Type DIAGNOSTIC_TEST

The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ShuntCheck

The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent

Exclusion Criteria

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the VP shunt.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No