NCT04883060

Pilot Testing for Midline Measuring Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Ventriculo-Peritoneal Shunt Infection

Interventions

Type	Name	Description
DEVICE	midline localizer	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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2021-05-12
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study