Clinical trial NCT00793416: ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
Official title: Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Normal Pressure Hydrocephalus
Keywords: Normal Pressure Hydrocephalus
Valve Adjustment
Blocked Shunt in NPH patients
Diagnosis of blockage
Lead sponsor: NeuroDx Development
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2008-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.

Detailed description: This study aims to correlate findings of ShuntCheck and MRI with the Radionuclide patency study. Patients will be enrolled if they have Hydrocephalus or IIH, present with symptoms of shunt obstruction and will need to undergo shunt patency test and an MRI along with standard of care radionuclide study. The ShuntCheck study will be conducted in a clinic, doctor's office or in an emergency room by the treating physician or by trained health care professionals.

Also, patients who are found with shunt obstruction as diagnosed by Radionuclide study will undergo shunt revision and the findings of the study will be correlated with operative findings. Post Shunt replacement patients who also receive adjustable valve will be evaluated with shunt Check, before and after adjustment of valves to detect changes in flow as detected by shunt check.

This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.

Approximately 20 subjects will be enrolled in a single site in this proof of concept, physician sponsored study. An approved, commercial device will be available to the site prior to start of the study.

Eligibility criteria: Inclusion Criteria:

1. Adult Patients \> 35 years capable and willing to consent for their participation or consent obtained from a legal guardian.
2. Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction
3. Patients are candidates for shunt patency procedures in the elective extension

Exclusion Criteria:

1. Patients \<35 years of age
2. Patients with symptoms attributable to valve malfunction or shunt infection
3. Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency.
4. Patients with edema or wound of skin overlying the shunt tissue.
5. Patients not capable or not willing to consent to participate in the study

Primary outcomes:
measure: Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction
timeFrame: Pre and post shunt revision surgery
Secondary outcomes:
measure: To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study
timeFrame: Pre and post shunt revision surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Daniele Rigamonti, MD
role: PRINCIPAL_INVESTIGATOR
References: