NCT00583336

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

7.8 years

First QC Date

December 20, 2007

Last Update Submit

June 22, 2015

Conditions

CSF Flow Through the Shunt of a Hydrocephalus Patient

Outcome Measures

Primary Outcomes (1)

  • ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested

    Tested in single visit

Secondary Outcomes (1)

  • ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction

    Single visit

Study Arms (1)

Diagnostic

EXPERIMENTAL
Device: ShuntCheck

Interventions

ShuntCheckDEVICE

Thermal dilution test for CSF flow

Diagnostic

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02215, United States

RECRUITING

Study Officials

  • Joseph R Madsen, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph R Madsen, MD

CONTACT

(617) 355-6005Joseph.Madsen@childrens.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

September 1, 2007

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

US(1)