Feasibility Study for a Prone Positioning Device in Neurosurgery
This study is testing a new prototype prone positioning device. This device is designed to help patients lie comfortably and safely on their stomach during long neurosurgical procedures for epilepsy that use an intraoperative MRI (iMRI). Researchers want to see if this new device works well and if it can reduce problems like skin sores or blood clots (pulmonary embolism) that can happen with current positioning methods. They will observe how many devices meet functional requirements and if any are damaged during use. The study is currently unclear on its status and plans to enroll 5 adult patients who are having these specific neurosurgical procedures at the University of Kansas Medical Center.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 5 participants. It is not specified if it is randomized, open-label, or blinded.
- What's involved
- Patients will be placed on the prototype prone positioning device during their neurosurgical procedures that utilize intraoperative MRI. Observations will be made during and immediately after each procedure through study completion, an average of 1 year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Observations will be made during and immediately after each procedure through study completion, an average of 1 year.
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iMRI Prone Positioning Frame Design Feasibility Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael Kinsman, MD · PRINCIPAL_INVESTIGATOR · [email protected]
Who to contact
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Exclusion
What this trial measures
- Number of devices that meet functional requirementsDuring and immediately after each through study completion, an average of 1 year
The device will be evaluated for meeting its primary function during each use. The primary function is to support the patient in the prone position in the MRI machine during neurosurgical procedures. Whether it fulfills its function will be determined through feedback received from the staff involved in its use which may include nurses, MRI technologists, anesthesia providers, and surgeons. This will be a pass/fail criteria.
- Number of devices that are damaged during useDuring and immediately after each through study completion, an average of 1 year
The device will be inspected for physical damage during and after each use. It will be inspected for bending, cracks, mechanical wear, or any other type of damage which could affect the device's safety or ability to serve its primary function. The type and severity of the damage will be recorded after each use and evaluated by the investigators. This will be a pass/fail criteria.