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Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011566
Recruitment Status : Enrolling by invitation
First Posted : July 8, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
NeuroDx Development
Information provided by (Responsible Party):
Naomi Abel, University of South Florida

Brief Summary:
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.

Condition or disease Intervention/treatment
Hydrocephalus, Normal Pressure Diagnostic Test: ShuntCheck

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Group/Cohort Intervention/treatment
ShuntCheck
Participants will be administered the ShuntCheck diagnostic test.
Diagnostic Test: ShuntCheck
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.




Primary Outcome Measures :
  1. Specificity of ShuntCheck test [ Time Frame: 15 minutes ]
  2. Negative Predictive Value of ShuntCheck test [ Time Frame: 15 minutes ]

Secondary Outcome Measures :
  1. Specificity of performing ShuntCheck test twice [ Time Frame: 60 minutes ]
  2. Negative Predictive Value of performing ShuntCheck test twice [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of asymptomatic normal pressure hydrocephalus research subjects who have a ventriculoperitoneal shunt with a single ventricular catheter implanted for adult hydrocephalus and are visiting for routine care. Evaluation will be within 2 weeks of shunt placement.
Criteria

Inclusion Criteria:

  • Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.
  • Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker 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 ventriculoperitoneal shunt.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011566


Locations
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United States, Florida
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
NeuroDx Development
Investigators
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Principal Investigator: Naomi Abel, MD University of South Florida
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Responsible Party: Naomi Abel, Assistant Professor, College of Medicine Neurosurgery, University of South Florida
ClinicalTrials.gov Identifier: NCT04011566    
Other Study ID Numbers: Pro00040697
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At present there is no plan to share any individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Naomi Abel, University of South Florida:
Asymptomatic Normal Pressure Hydrocephalus
Ventriculoperitoneal Shunt
Additional relevant MeSH terms:
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Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases