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Prototype positioning device for Pulmonary Embolism
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during and immediately after each through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am an adult getting a specific epilepsy treatment at KUMC.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of devices that are damaged during use
Number of devices that meet functional requirements
Secondary outcome measures
Number of patients with skin complications
Number of patients with thromboembolic complications
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prototype positioning deviceExperimental Treatment1 Intervention
The prototype prone positioning device will be used during neurosurgical procedures utilizing intraoperative MRI.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
467 Previous Clinical Trials
169,253 Total Patients Enrolled
Continuum Educational TechnologiesUNKNOWN
Michael Kinsman, MDPrincipal Investigatormkinsman2@kumc.edu
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently ongoing efforts to enroll patients in this clinical trial?
"According to information from clinicaltrials.gov, this specific research study is not currently in the recruitment phase. The trial's initial posting was on April 1st, 2024 and its latest update occurred on April 24th, 2024. While this particular trial is inactive in terms of recruitment, there are presently 346 other trials actively seeking participants."
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