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OpenTrials
Completed

NCT Number: NCT04883060

Pilot Testing for Midline Measuring Device

Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. The investigators have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew Howard III). This is not patented it at this time. There is no company involved in manufacturing (assembly was completed with the help of the hospital's machine shop).

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery

Exclusion criteria

  • Patients who are not able to consent

Treatment and study plan

midline localizer

Device

a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.

Primary outcomes

  1. Midline Localization

    Time frame: Immediate postop, an average of 4 hours

    The average distance separating the staple from the lateral edge of the sagittal sinus

Secondary outcomes

  1. Burr Hole Placement

    Time frame: Immediately Post-op, an average of 4 hours

    Number of participants in which their Burr hole placement was between 3 and 4 cm away from anatomical midline

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Acronym: MMD

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 12, 2021
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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