Pilot Testing for Midline Measuring Device

NCT ID: NCT04883060

Last Updated: 2024-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-07-01

Brief Summary

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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).

Detailed Description

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Conditions

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Ventriculo-Peritoneal Shunt Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Patients undergoing ventriculoperitoneal surgery where the midline localizer was used

Group Type EXPERIMENTAL

midline localizer

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Matthew Howard

Professor of Neurosurgery, Head of Department of Neurosurgery at University of Iowa

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Univeristy of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201704798

Identifier Type: -

Identifier Source: org_study_id

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