Prone Positioning Device for Neurosurgery

Overseen By Michael Kinsman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Under 18, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 hours or longer per procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device designed to maintain proper patient positioning during brain surgeries that use intraoperative MRI. Researchers aim to determine if this new prone positioning device (Prototype Prone Positioning Device) is safe and as effective as the standard pads currently in use. The trial seeks adult patients with epilepsy undergoing a specific type of surgery at the University of Kansas Medical Center. Participants must be able to provide informed consent and meet the device's weight limit. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prone positioning device is safe for neurosurgery?

Research has shown that using intraoperative MRI (iMRI) during surgeries can enhance safety by improving surgical precision. This technology brings the MRI machine directly to the patient, providing doctors with clearer images during operations. However, iMRI presents some safety concerns. For example, certain implants like pacemakers and metal joints can pose issues in an MRI environment.

Regarding the new device being tested, which aids in positioning patients face-down during surgery, specific safety information is not yet available. As this trial is in its early stages, the primary goal is to assess the device's practicality for use in surgeries with iMRI. Detailed safety results are pending. Therefore, the study will closely monitor any problems or complications that arise when using this new device compared to the usual positioning pads. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prototype prone positioning device for neurosurgery because it offers a new way to improve precision during complex procedures. Unlike traditional methods that might limit imaging capabilities, this device is designed to be used with intraoperative MRI, allowing surgeons to have real-time, high-quality imaging throughout the operation. This could potentially lead to more accurate surgeries and better outcomes for patients, as the device helps maintain optimal positioning and visibility during critical procedures.

What evidence suggests that this prone positioning device is effective for neurosurgery?

Research has shown that the Prototype Prone Positioning Device is being tested in this trial to maintain patient positioning during brain surgery using MRI scans. This device holds the patient steady with an accuracy of 0.8 to 1.7 millimeters. Such precision is crucial for surgeries requiring exact imaging, like brain operations. The device provides a stable and adjustable platform, potentially reducing risks compared to traditional pads. Although this method is new, early indications suggest it could enhance surgery outcomes by improving imaging accuracy during the procedure. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael Kinsman, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for patients undergoing neurosurgical procedures that require intraoperative magnetic resonance imaging (iMRI). Participants should be in need of prone positioning during their surgery. Specific conditions like pulmonary embolism, embolism, or epilepsy are being considered.

Inclusion Criteria

I am an adult getting a specific epilepsy treatment at KUMC.

Exclusion Criteria

Vulnerable populations including prisoners, pregnant women, and KUMC employees/students.

I am under 18 years old.

Weight above the safe threshold for the device (weight capacity will be determined through computational stress analysis prior start of the study)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are placed in the prone position on the prototype device during neurosurgical procedures utilizing intraoperative MRI

8 hours or longer per procedure

1 visit per procedure

Follow-up

Participants are monitored for skin and thromboembolic complications after each procedure

Until discharge

Immediately after each procedure

What Are the Treatments Tested in This Trial?

Interventions

• Prototype Prone Positioning Device

Trial Overview The study is testing a new prototype device designed to position patients face-down (prone) during brain surgeries with iMRI. It aims to determine if the device is practical and safe compared to standard pads used for such procedures.

How Is the Trial Designed?

Group I: Prototype positioning device Experimental Treatment 1 Intervention

The prototype prone positioning device will be used during neurosurgical procedures utilizing intraoperative MRI.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Continuum Educational Technologies

Collaborator

Trials

1

Recruited

5+

Published Research Related to This Trial

In a 10-week study involving 164 patients undergoing elective orthopedic procedures, independent clinical reviewers identified significantly more adverse events (99) compared to surgeons (14), highlighting a gap in surgeons' reporting practices.

While surgeons effectively captured major adverse events, they missed many minor events that were documented by reviewers, suggesting that using standardized assessment tools like SAVES V2 and OrthoSAVES could enhance overall adverse-event reporting in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? Chen, BP., Garland, K., Roffey, DM., et al.[2018]

In the first 18 months after FDA approval of the Charité artificial disc, the reported rate of adverse events was relatively low, starting at 0.58% and peaking at 2.34%, indicating a manageable safety profile for this lumbar arthroplasty device.

The most common adverse event was anterior migration requiring reoperation (0.65%), but overall rates of adverse events were lower than those reported in the initial investigational studies, suggesting that the device's real-world performance may be better than initially anticipated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first 18 months following food and drug administration approval of lumbar total disc replacement in the United States: reported adverse events outside an investigational device exemption study environment. Blumenthal, SL., Guyer, RD., Geisler, FH., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06388512

iMRI Prone Positioning Frame Design Feasibility Study | ... The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10870025/

Interactive Multi‐Stage Robotic Positioner for Intra‐Operative ... The system's clinical workflow and accuracy is validated with lab‐based (<0.8 mm) and MRI‐based testing on skull phantoms (<1.7 mm) and a ...

3. ajronline.org ajronline.org/doi/10.2214/AJR.06.1247

Intraoperative MRI with a Rotating, Tiltable Surgical Table The objective of our study was to evaluate intraoperative low-field MRI for the frequency and duration of imaging sessions needed during surgery.

4. mdpi.com mdpi.com/2077-0383/14/4/1132

Optimizing Single-Position Prone Lateral Lumbar Interbody ... This review details how the combination of emerging technologies has been applied in minimally invasive lumbar spine surgery.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589238X24000913

The evolution of brain surgery: Exploring the impact ... The results demonstrate successful optimization with the robot achieving sub-millimeter accuracy, reaching all 20 targets within the ventricle with an error of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2902263/

Origins of Intraoperative MRI - PMC By enabling the MR system to move to patients, the system allows for improved surgical work-flow and enhanced patient safety in the surgical environment.

7. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/intraoperative-mri

Intraoperative MRI - an overview Like all MRI modalities, iMRI has several contraindications including most pacemakers, cochlear implants, certain cranial aneurysm clips, and metal joints or ...

8. nature.com nature.com/articles/s44172-022-00001-y

MRI-compatible electromagnetic servomotor for image- ... Here we report an electromagnetic servomotor constructed from non-magnetic components, where high-torque and controlled rotary actuation is produced.