Trial record 1 of 149 for:
shunt patency
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients (SCNPH)
This study has been completed.
Sponsor:
NeuroDx Development
ClinicalTrials.gov Identifier:
NCT01323764
First Posted: March 28, 2011
Last Update Posted: October 20, 2015
Collaborators:
Sinai Hospital of Baltimore
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
NeuroDx Development
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | March 21, 2011 | |||||||||
| First Posted Date ICMJE | March 28, 2011 | |||||||||
| Last Update Posted Date | October 20, 2015 | |||||||||
| Start Date ICMJE | June 2011 | |||||||||
| Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Sensitivity and specificity of ShuntCheck vs SPS [ Time Frame: Day 1 ] The primary efficacy objective is the sensitivity and specificity of the ShuntCheck test. The performance of ShuntCheck test will be compared to the radionuclide scanning done on the day of ShuntCheck administration. Primary efficacy of the SC and SC+MP test will be determined by comparing SC and SC+MP performance to results of radionuclide scanning according to a standard 2 x 2 table, with a Positive test result defined as evidence of shunt obstruction. |
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01323764 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients | |||||||||
| Official Title ICMJE | A Double- Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device, to Radionuclide Shunt Patency Test in Evaluating Shunt Function in Patients With Adult Hydrocephalus With Possible Shunt Obstruction | |||||||||
| Brief Summary | The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts when shunt obstruction is suspected and a diagnostic procedure such as radionuclide shunt patency testing (SPS) is required. | |||||||||
| Detailed Description | The primary objective is to demonstrate that the accuracy of SC and SC+MP for determining whether a VP shunt is patent or obstructed is statistically no different than the accuracy of the accepted standard test, radionuclide shunt patency study, when performed simultaneously. A secondary objective is to determine SC and SC+MP results in the presence of possible partial obstruction, which defined as subjects with radionuclide clearance measured by T1/2 of 8 to 10 minutes. A secondary objective is to compare ShuntCheck flow rate results to simultaneous radionuclide clearance as measured by T1/2. A secondary objective is to demonstrate that ShuntCheck flow rate results are statistically equivalent to simultaneous radionuclide clearance measured by T1/2 |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase | Phase 4 | |||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Diagnostic |
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| Condition ICMJE | Hydrocephalus | |||||||||
| Intervention ICMJE | Device: ShuntCheck test
Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
Other Name: ShuntCheck |
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| Study Arms | Active Comparator: Radionuclide SPS
Radionuclide Shunt Patency Study
Intervention: Device: ShuntCheck test |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Estimated Enrollment ICMJE | 20 | |||||||||
| Completion Date | July 2015 | |||||||||
| Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 35 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01323764 | |||||||||
| Other Study ID Numbers ICMJE | NDxDev-SCMP-2012 R43NS067770-01A1 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | NeuroDx Development | |||||||||
| Study Sponsor ICMJE | NeuroDx Development | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | NeuroDx Development | |||||||||
| Verification Date | October 2015 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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