Physician Preference Study of ShuntCheck - Madsen | NCT00583336

Studies
Physician Preference Study of ShuntCheck - Madsen

NCT00583336

Sponsor

NeuroDx Development

Status

Unknown status

Last Update Posted

Jun 23, 2015Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

CSF Flow Through the Shunt of a Hydrocephalus Patient

Interventions

ShuntCheck

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
07-07-0277

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jul 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 28, 2007

First Posted Date

Dec 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Name	Class
Boston Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.

Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic	Experimental		Device: ShuntCheck

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ShuntCheck	Device	Thermal dilution test for CSF flow	Diagnostic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested		Tested in single visit

Secondary Outcomes

Measure	Description	Time Frame
ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction		Single visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
Subjects must be physically stable as determined by the physician.

Exclusion Criteria:

Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
Subjects unable to lie supine with head elevated 30 degrees or less
Subjects who have had shunt surgery within two weeks.
Inability or unwillingness of subject to endure the test.
Other judgments of the investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joseph R Madsen, MD	Contact	(617) 355-6005		Joseph.Madsen@childrens.harvard.edu

Overall Officials

Name	Affiliation	Role
Joseph R Madsen, MD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston	Recruiting	Boston	Massachusetts	02215	United States