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

NCT00793416 | Withdrawn Phase 4

• 1 other identifier: NDX01-22-2003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Pressure Hydrocephalus

Keywords

Normal Pressure Hydrocephalus; Valve Adjustment; Blocked Shunt in NPH patients; Diagnosis of blockage

Outcome Measures

Primary Outcomes (1)

• Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction

  Pre and post shunt revision surgery

Secondary Outcomes (1)

• To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study

  Pre and post shunt revision surgery

Study Arms (1)

ShuntCheck measure

EXPERIMENTAL

All patients will have ShuntCheck measurements along with radionuclide shunt patency testing.

Device: Shunt flow detection

Interventions

Shunt flow detection DEVICE

Shunt flow detection based upon ShuntCheck results compared to radionuclide test results

ShuntCheck measure

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NeuroDx Development: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daniele Rigamonti, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

US (1)