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| ID | Type | Description | Link |
|---|---|---|---|
| R44NS067772 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCMP plus Imaging | Experimental | SCMP plus Imaging will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. |
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| Imaging Alone | Active Comparator | Imaging alone will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. |
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| SCMP Rule Out for Low Risk Cases | Experimental | SCMP results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction |
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| Imaging Rule for Low Risk Cases | Active Comparator | Imaging results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Negative Predictive Value in ruling out shunt malfunction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ShuntCheck-Micro-Pumper (SCMP) | Device | ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy compared with clinical outcomes | SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery. | 7 days |
| Positive Predictive Value (PPV) | Specifically to demonstrate that SCMP positive (Flow Not Confirmed - FNC) plus imaging positive (enlarged ventricles) results yield a higher positive predictive value than imaging positive alone. | 7 days |
| Negative Predictive Value (NPV) | Specifically to demonstrate that SCMP negative (Flow Confirmed - FC) plus imaging negative (non-enlarged ventricles) results yield a higher negative predictive value than imaging negative alone. | 7 days |
| Safety | To determine if any adverse events were caused by the device or procedure while using the study device. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Rule Out for Low Risk Cases | To demonstrate that SCMP plus Physician's judgment is comparable to Physician's judgment plus imaging in ruling out shunt malfunction in patients judged to be "Unlikely to require shunt surgery" | 7 days |
| Increased PPV and NPV for Uncertain Cases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph R Madsen, MD | Contact | 617) 355-6005 | Joseph.Madsen@childrens.harvard.edu | |
| Eun-Hyoung Park | Contact | 617.355.6558 | Eun-Hyoung.Park@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph R Madsen, MD | Boston Children's Hospital | Study Chair |
| George I Jallo, MD | Johns Hopkins University | Principal Investigator |
| David A Frim, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A I dePont Hospital for Children | Recruiting | Wilmington | Delaware | 19803 | United States |
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| SCMP plus Imaging in Uncertain Cases | Experimental | SCMP plus imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value |
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| Imaging alone in Uncertain Cases | Active Comparator | Imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery - to determine Positive and Negative Predictive Value |
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| Imaging | Device | Imaging of ventricle size |
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To demonstrate that SCMP plus imaging results yield higher positive and negative predictive values than imaging alone in patients who are admitted for observation. |
| 7 days |
| University of Chicago Comer Children's Hospital |
| Principal Investigator |
| David Sandberg, MD | University of Texas-Houston/Children's Memorial Hermann Hospital | Principal Investigator |
| Phillip B Storm, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Joseph J Zorc, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Robert W Hickey, MD | University of Pittsburgh | Principal Investigator |
| Mandeep Tamber, MD | University of Pittsburgh | Principal Investigator |
| Lisa H Merck, MD MPH | Rhode Island Hospital | Principal Investigator |
| Petra M Klinge, MD PhD | Rhode Isalnd Hospital | Principal Investigator |
| Robert F Keating, MD | Children's National Research Institute | Principal Investigator |
| James Chamberlain, MD | Children's National Research Institute | Principal Investigator |
| Jeffrey R Leonard, MD | Nationwide Children's Hospital | Principal Investigator |
| Julie C Leonard, MD MPH | Nationwide Children's Hospital | Principal Investigator |
| Joseph H Piatt, MD | Alfred I. duPont Hospital for Children | Principal Investigator |
| Jonathan E Bennett, MD | Alfred I. duPont Hospital for Children | Principal Investigator |
| David Chesler, MD | Stony Brook Medical Center | Principal Investigator |
| Children's National Medical Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| University of Chicago Comer Children's Hospital | Recruiting | Chicago | Illinois | 60637 | United States |
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| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Stony Brook Medical Center | Recruiting | Stony Brook | New York | 11794 | United States |
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| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| University of Texas-Houston/Children's Memorial Hermann Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007090 | Image Interpretation, Computer-Assisted |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
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