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Prone Positioning Device for Neurosurgery

N/A

Waitlist Available

Led By Michael Kinsman, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients undergoing prone laser interstitial thermal therapy procedures for epilepsy at the University of Kansas Medical Center (KUMC)

Be older than 18 years old

Must not have

Patients under the age of 18

Patients who are unable to provide informed consent for participation in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during and immediately after each through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if a new adjustable prone positioning frame is safe and effective for use during neurosurgical procedures that involve intraoperative magnetic resonance imaging (iMRI). Researchers will assess if using this

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications related to the use of the new positioning frame, although these will be closely monitored against risks associated with conventional methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am able to understand and agree to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during and immediately after each through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during and immediately after each through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and during and immediately after each through study completion, an average of 1 year for reporting.