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NCT02786706 · ClinicalTrials.gov registry record

Automated Measurement of Optic Nerve Sheath Diameter

A clinical trial, sponsored by University of Michigan.

Completed
Registry status
75
Enrollment target

NCT02786706: Completed study, sponsored by University of Michigan.

NCT02786706 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02786706 has completed, sponsored by University of Michigan.

COMPLETED
Registry status
75 participants
Enrollment target

Study Summary

Optic Nerve Ultrasound (ONUS) is a promising non-invasive tool for the detection of raised Intracranial Pressure (ICP). Variability in the optimal Optic Nerve Sheath Diameter (ONSD) threshold corresponding to elevated ICP in multiple studies limits the value of ONUS in clinical practice. The investigators goal is to develop and validate an automated image analysis algorithm for standardization of ONSD measurement from ultrasound videos. Patients with acute brain injury requiring invasive ICP monitoring will undergo bedside ONUS, with blinded ONSD measurement by an expert investigator. The image analysis algorithm will then be used to measure ONSD and accuracy determined compared to the "reference standard" expert measurement.

Primary Outcome

The primary endpoint for determination of accuracy of automated image analysis measurement of Optic Nerve Sheath Diameter (ONSD) will be ONSD measurement performed by an expert investigator with \>5 years experience with ONUS and ONSD measurement.

Interventions

  • DEVICE Optic nerve ultrasound

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2015-07
Est. Completion 2019-12-31
University of Michigan

1,327 total trials

What the finished NCT02786706 record still lists

NCT02786706 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Optic nerve ultrasound is the first listed.

NCT02786706 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02786706 about?

NCT02786706 is a clinical study titled "Automated Measurement of Optic Nerve Sheath Diameter". Optic Nerve Ultrasound (ONUS) is a promising non-invasive tool for the detection of raised Intracranial Pressure (ICP). Variability in the optimal Optic Nerve Sheath Diameter (ONSD) threshold corresponding to elevated ICP in multiple studies limits the value of ONUS in clinical practice. The investi...

What is the current status of trial NCT02786706?

This trial is currently completed. The enrollment target is 75 participants. The study started on 2015-07. Estimated completion is 2019-12-31.

What interventions are being tested in trial NCT02786706?

The interventions under investigation include: Optic nerve ultrasound (DEVICE).

Who is sponsoring clinical trial NCT02786706?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02786706, the US trial registry maintained by the National Library of Medicine. NCT02786706 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.