NCT04883060: MMD

Pilot Testing for Midline Measuring Device

Completed NA Results posted Last updated 30 January 2024

What this trial tests

NA trial testing midline localizer in Ventriculo-Peritoneal Shunt Infection in 40 participants. Completed in 1 July 2019.

Timeline

1 January 2019

Primary endpoint
1 July 2019

1 July 2019

Quick facts

Lead sponsor	University of Iowa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 January 2019
Primary completion	1 July 2019
Estimated completion	1 July 2019
Sites	1 location across United States

Drugs / interventions tested

• midline localizer

Conditions studied

• Ventriculo-Peritoneal Shunt Infection — all drugs for Ventriculo-Peritoneal Shunt Infection →

Sponsor

University of Iowa

Who can join

Adults 21 to 85, any sex, with Ventriculo-Peritoneal Shunt Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Midline Localization Primary · Immediate postop, an average of 4 hours

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

Group	Value	95% CI
Intervention	0.9	± 1.6

Burr Hole Placement Secondary · 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

Group	Value	95% CI
Intervention	37

Adverse events — posted to ClinicalTrials.gov

Time frame: From the start of surgery until surgical closure, up to 2.5 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (2 terms — click to expand)

Reaction	System	Intervention
Incorrect Burr Hole Placement	Surgical and medical procedures	—
Ventricle Catheter Misplacement	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT04883060 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.