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出境医 / 临床实验 / Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Study Description
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 |
Study Design
| 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 2022 |
| Estimated Study Completion Date : | June 2022 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- Specificity of ShuntCheck test [ Time Frame: 15 minutes ]
- Negative Predictive Value of ShuntCheck test [ Time Frame: 15 minutes ]
Secondary Outcome Measures :
- Specificity of performing ShuntCheck test twice [ Time Frame: 60 minutes ]
- Negative Predictive Value of performing ShuntCheck test twice [ Time Frame: 60 minutes ]
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Naomi Abel, MD | 813 259-0904 | nabel@usf.edu | |
| Contact: Konrad Bach, MD | 813 259-8898 | kbach@usf.edu |
Locations
| United States, Florida | |
| University of South Florida Department of Neurological Surgery and Brain Repair | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Naomi Abel, MD 813-259-0904 nabel@health.usf.edu | |
| Contact: Deborah Scott Scott, BA 813 259-0616 descott@health.usf.edu | |
| Principal Investigator: Naomi Abel, MD | |
Sponsors and Collaborators
University of South Florida
NeuroDx Development
Investigators
| Principal Investigator: | Naomi Abel, MD | University of South Florida |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 18, 2019 | ||||||||
| First Posted Date | July 8, 2019 | ||||||||
| Last Update Posted Date | April 27, 2021 | ||||||||
| Actual Study Start Date | June 11, 2019 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus | ||||||||
| Official Title | Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | Hydrocephalus, Normal Pressure | ||||||||
| Intervention | Diagnostic Test: ShuntCheck
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
|
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| Study Groups/Cohorts | ShuntCheck
Participants will be administered the ShuntCheck diagnostic test.
Intervention: Diagnostic Test: ShuntCheck
|
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| Publications * | Not Provided | ||||||||
|
* 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 | Recruiting | ||||||||
| Estimated Enrollment |
20 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 2022 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 40 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04011566 | ||||||||
| Other Study ID Numbers | Pro00040697 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Naomi Abel, University of South Florida | ||||||||
| Study Sponsor | University of South Florida | ||||||||
| Collaborators | NeuroDx Development | ||||||||
| Investigators |
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| PRS Account | University of South Florida | ||||||||
| Verification Date | April 2021 | ||||||||
