ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients

This study has been withdrawn prior to enrollment.
(Loss of study staffing)
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
NeuroDx Development
ClinicalTrials.gov Identifier:
NCT00793416
First received: November 17, 2008
Last updated: October 28, 2013
Last verified: October 2013

November 17, 2008
October 28, 2013
November 2008
August 2012   (final data collection date for primary outcome measure)
Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction [ Time Frame: Pre and post shunt revision surgery ] [ Designated as safety issue: No ]
Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction [ Time Frame: Pre and post valve adjustment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00793416 on ClinicalTrials.gov Archive Site
To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study [ Time Frame: Pre and post shunt revision surgery ] [ Designated as safety issue: Yes ]
To assess any adverse events that arise from conducting ShuntCheck test To asess the cost effectiveness of ShuntCheck screening upon completion of the study [ Time Frame: Pre and post Valve Adjustment and 4 weeks post adjustment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test

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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Normal Pressure Hydrocephalus
Device: Shunt flow detection
Shunt flow detection based upon ShuntCheck results compared to radionuclide test results
Experimental: ShuntCheck measure
All patients will have ShuntCheck measurements along with radionuclide shunt patency testing.
Intervention: Device: Shunt flow detection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
35 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00793416
NDX01-22-2003
No
NeuroDx Development
NeuroDx Development
Johns Hopkins University
Principal Investigator: Daniele Rigamonti, MD Johns Hopkins School of Medicine
NeuroDx Development
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP