NCT03451669

Brief Summary

There have been reports in the past of using thermal cameras to demonstrate flow in the tubing as a surrogate of proper shunt function. This was shown to have almost 90% accuracy at determining proper functioning but required expensive equipment that was not universally available. There is now smart phone based thermal camera technology (Flir One: http://www.flir.com/flirone/) that could make this technique widely available for health care use. The goal of the study is to determine if this device can demonstrate flow in the distal tubing of a VP shunt.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

February 23, 2018

Last Update Submit

May 8, 2020

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

  • Determine if a smartphone based thermal camera can determine flow in the distal tubing of a VP shunt.

    3 years

Study Arms (2)

Shunt suspected to be functioning

Shunt suspected to not be functioning

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with VP shunts at the University of Pennsylvania, Department of Neurosurgery

You may qualify if:

  • Patients with known VP shunt
  • Status of shunt function known.
  • Patients with well healed wounds (no immediately post op patients)

You may not qualify if:

  • Patients in urgent need of shunt revision
  • Age less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 2, 2018

Study Start

April 16, 2018

Primary Completion

November 30, 2019

Study Completion

December 2, 2019

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)