EpilepsyNCT06388512
iMRI Prone Positioning Frame Design Feasibility Study
A study testing prototype prone positioning device in people with Epilepsy and Pulmonary Embolism, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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 utilize intraoperative magnetic resonance imaging (iMRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Pulmonary Embolism
- What is being tested?
- prototype prone positioning device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 4 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing prone laser interstitial thermal therapy procedures for epilepsy at the University of Kansas Medical Center (KUMC).
Who cannot join
- Patients under the age of 18
- Patients who are unable to provide informed consent for participation in the study
- Weight above the safe threshold for the device (weight capacity will be determined through computational stress analysis prior start of the study)
- Patients who do not speak English fluently enough to provide informed consent in English
- Vulnerable populations including prisoners, pregnant women, and KUMC employees/students.
Trial locations and contacts
1 site in 1 country.
Michael Kinsman, MD contact
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
Andrew Guillotte, MD, 309-648-7036, aguillotte@kumc.edu
Anand Dharia, MD
About this study
Official title: Intraoperative MRI Prone Position Support 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 utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:
- Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?
- Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device.
Read the detailed description
Laser Interstitial Thermal Therapy (LITT) ablations are neurosurgical procedures which are performed for several indications including brain tumors and epilepsy. LITT procedures are performed utilizing intraoperative magnetic resonance imaging (MRI) scans. Some of these procedures must be performed in the prone position and can last 8 hours or longer. Investigators have observed several minor skin breakdown complications as well as a few major thromboembolic complications during these long prone procedures. Investigators hypothesize that the cause of the major thromboembolic complications are a result of compression of the femoral veins by the gel pads used to support the patient in the prone position. Many long spine surgeries are performed in the prone position and fewer episodes of skin pressure wounds are experienced and no major intraoperative thromboembolic complications. The study team hypothesizes that the difference is the way that the spine surgery pads support the hips does not compress the femoral vein, therefore significantly decreasing the risk of developing a thrombus intraoperatively.
The aim of this project is to design a modular, adjustable plastic frame to support the spine surgery Jackson table chest and hip pads. Investigators will produce a prototype of the frame and test it during LITT procedures. The prototype of the frame will be 3D printed using the 3D printer owned by the Department of Neurosurgery. The hypothesis is that supporting the patient in the prone position using similar positioning methods to those used for spine surgeries will reduce the rate of skin pressure injuries and prevent future major thromboembolic complications.
- Conditions
- Epilepsy, Pulmonary Embolism
- Being tested
- prototype prone positioning device
- Keywords
- laser interstitial thermal therapy
- Medical subject headings
- Epilepsy, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prototype prone positioning deviceDevice
The prototype prone positioning device will be used during neurosurgical procedures utilizing intraoperative MRI.
| Study group | Role | What they receive |
|---|---|---|
| Prototype positioning device | Experimental | The prototype prone positioning device will be used during neurosurgical procedures utilizing intraoperative MRI. Receives: Device: prototype prone positioning device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of devices that meet functional requirements
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.
Measured: During and immediately after each through study completion, an average of 1 year
Number of devices that are damaged during use
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.
Measured: During and immediately after each through study completion, an average of 1 year
Secondary outcomes (2)
Number of patients with skin complications
Each patient's skin will be examined after each procedure to evaluate for pressure injuries related to the prone positioning device. Size and severity of the skin injuries will be documented.
Measured: Immediately after each procedure
Number of patients with thromboembolic complications
Each patient will be monitored for thromboembolic complications such as deep vein thrombosis or pulmonary embolism.
Measured: During and after each procedure until the patient is discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start4 Sep 2024 (estimated)
- Primary completion4 Sep 2025 (estimated)
- Study completion4 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Continuum Educational Technologies
- Responsible party
- Sponsor
- Investigators
- Michael Kinsman, MD, Principal investigator, mkinsman2@kumc.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388512
- Sponsor's protocol ID
- STUDY00160044
- Status last verified
- May 2024
- First submitted
- 2 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hong B, Yoon SH, Park SY, Song S, Youn A, Hwang JG. Cardiac Arrest from Patient Position Change after Spine Surgery on a Jackson Table. Acute Crit Care. 2019 Feb;34(1):86-91. doi: 10.4266/acc.2016.00794. Epub 2017 Feb 20.
PubMed 31723910Cho JK, Han JH, Park SW, Kim KS. Deep vein thrombosis after spine operation in prone position with subclavian venous catheterization: a case report. Korean J Anesthesiol. 2014 Jul;67(1):61-5. doi: 10.4097/kjae.2014.67.1.61. Epub 2014 Jul 29.
PubMed 25097742Gebhard CE, Zellweger N, Gebhard C, Hollinger A, Chrobok L, Stahli D, Schonenberger CM, Todorov A, Aschwanden M, Siegemund M. Prone Positioning as a Potential Risk Factor for Deep Vein Thrombosis in COVID-19 Patients: A Hypothesis Generating Observation. J Clin Med. 2021 Dec 25;11(1):103. doi: 10.3390/jcm11010103.
PubMed 35011843Kanter DS, Mikkola KM, Patel SR, Parker JA, Goldhaber SZ. Thrombolytic therapy for pulmonary embolism. Frequency of intracranial hemorrhage and associated risk factors. Chest. 1997 May;111(5):1241-5. doi: 10.1378/chest.111.5.1241.
PubMed 9149576
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative MRI Prone Position Support Frame Design Feasibility Study
- ClinicalTrials.gov ID
- NCT06388512
- Acronym / sponsor ID
- STUDY00160044
- Conditions
- Epilepsy, Pulmonary Embolism
- Keywords
- laser interstitial thermal therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Continuum Educational Technologies
- Study start
- 4 Sep 2024 (estimated)
- Primary completion
- 4 Sep 2025 (estimated)
- Study completion
- 4 Sep 2025 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:
- Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?
- Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device.
Detailed description
Laser Interstitial Thermal Therapy (LITT) ablations are neurosurgical procedures which are performed for several indications including brain tumors and epilepsy. LITT procedures are performed utilizing intraoperative magnetic resonance imaging (MRI) scans. Some of these procedures must be performed in the prone position and can last 8 hours or longer. Investigators have observed several minor skin breakdown complications as well as a few major thromboembolic complications during these long prone procedures. Investigators hypothesize that the cause of the major thromboembolic complications are a result of compression of the femoral veins by the gel pads used to support the patient in the prone position. Many long spine surgeries are performed in the prone position and fewer episodes of skin pressure wounds are experienced and no major intraoperative thromboembolic complications. The study team hypothesizes that the difference is the way that the spine surgery pads support the hips does not compress the femoral vein, therefore significantly decreasing the risk of developing a thrombus intraoperatively.
The aim of this project is to design a modular, adjustable plastic frame to support the spine surgery Jackson table chest and hip pads. Investigators will produce a prototype of the frame and test it during LITT procedures. The prototype of the frame will be 3D printed using the 3D printer owned by the Department of Neurosurgery. The hypothesis is that supporting the patient in the prone position using similar positioning methods to those used for spine surgeries will reduce the rate of skin pressure injuries and prevent future major thromboembolic complications.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prototype positioning device | Experimental | Device: prototype prone positioning deviceThe prototype prone positioning device will be used during neurosurgical procedures utilizing intraoperative MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing prone laser interstitial thermal therapy procedures for epilepsy at the University of Kansas Medical Center (KUMC).
Key exclusion criteria (5 listed)
- Patients under the age of 18
- Patients who are unable to provide informed consent for participation in the study
- Weight above the safe threshold for the device (weight capacity will be determined through computational stress analysis prior start of the study)
- Patients who do not speak English fluently enough to provide informed consent in English
- Vulnerable populations including prisoners, pregnant women, and KUMC employees/students.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prototype prone positioning deviceThe prototype prone positioning device will be used during neurosurgical procedures utilizing intraoperative MRI. | Device | Prototype positioning device |
Primary outcome
Number of devices that meet functional requirements
Time frame: During 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 use
Time frame: During 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.
2 secondary outcomes
Number of patients with skin complications
Time frame: Immediately after each procedure
Number of patients with thromboembolic complications
Time frame: During and after each procedure until the patient is discharged.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31723910Hong B, Yoon SH, Park SY, Song S, Youn A, Hwang JG. Cardiac Arrest from Patient Position Change after Spine Surgery on a Jackson Table. Acute Crit Care. 2019 Feb;34(1):86-91. doi: 10.4266/acc.2016.00794. Epub 2017 Feb 20.
- Background: PubMed 25097742Cho JK, Han JH, Park SW, Kim KS. Deep vein thrombosis after spine operation in prone position with subclavian venous catheterization: a case report. Korean J Anesthesiol. 2014 Jul;67(1):61-5. doi: 10.4097/kjae.2014.67.1.61. Epub 2014 Jul 29.
- Background: PubMed 35011843Gebhard CE, Zellweger N, Gebhard C, Hollinger A, Chrobok L, Stahli D, Schonenberger CM, Todorov A, Aschwanden M, Siegemund M. Prone Positioning as a Potential Risk Factor for Deep Vein Thrombosis in COVID-19 Patients: A Hypothesis Generating Observation. J Clin Med. 2021 Dec 25;11(1):103. doi: 10.3390/jcm11010103.
- Background: PubMed 9149576Kanter DS, Mikkola KM, Patel SR, Parker JA, Goldhaber SZ. Thrombolytic therapy for pulmonary embolism. Frequency of intracranial hemorrhage and associated risk factors. Chest. 1997 May;111(5):1241-5. doi: 10.1378/chest.111.5.1241.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kinsman, MD contact
Michael Kinsman, MD principal investigator
mkinsman2@kumc.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prototype prone positioning device in people with Epilepsy and Pulmonary Embolism, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Guillotte, MD (3096487036, aguillotte@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of devices that meet functional requirements (time frame: During and immediately after each through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388512, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.