Pilot Testing for Midline Measuring Device

NCT04883060 | Completed Results FDA Device

• 1 other identifier: 201704798
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Midline Localization

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

  Immediate postop, an average of 4 hours

Secondary Outcomes (1)

• Burr Hole Placement

  Immediately Post-op, an average of 4 hours

Study Arms (1)

Intervention

EXPERIMENTAL

Patients undergoing ventriculoperitoneal surgery where the midline localizer was used

Device: midline localizer

Interventions

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.

Intervention

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are not able to consent

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Univeristy of Iowa

Iowa City, Iowa, 52242, United States

Location

Results Point of Contact

• Title: Matthew Howard III
• Organization: University of Iowa

matthew-howard@uiowa.edu

(319) 356-8468

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery, Head of Department of Neurosurgery at University of Iowa

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: January 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)