- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03451669
Thermal Camera Detection of Ventriculoperitoneal Shunt Flow (Infrared Shunt)
May 8, 2020 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with VP shunts at the University of Pennsylvania, Department of Neurosurgery
Description
Inclusion Criteria:
- Patients with known VP shunt
- Status of shunt function known.
- Patients with well healed wounds (no immediately post op patients)
Exclusion Criteria:
- Patients in urgent need of shunt revision
- Age less than 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Shunt suspected to be functioning
|
Shunt suspected to not be functioning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if a smartphone based thermal camera can determine flow in the distal tubing of a VP shunt.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2018
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
December 2, 2019
Study Registration Dates
First Submitted
February 23, 2018
First Submitted That Met QC Criteria
February 23, 2018
First Posted (Actual)
March 2, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2020
Last Update Submitted That Met QC Criteria
May 8, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 827169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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