Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824546
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-03-22
Brief Title:
uSINE-PAMS Artificial Intelligence Driven Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
Sponsor:
National Neuroscience Institute
Organization:
National Neuroscience Institute
Study Overview
Official Title:
uSINE-PAMS Artificial Intelligence Driven Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to test the effectiveness of uSINE-PAMS technology for lumbar puncture compared to traditional landmark-based technique uSINE is a machine-learning software designed to aid the operators in ultrasound-guided lumbar puncture while PAMS is a two-part hardware to translate data from ultrasound to accurate needle insertion and angulation
Detailed Description:
Lumbar puncture LP is a routine invasive procedure performed for the diagnosis and treatment of central nervous system disorders The traditional landmark-based method is associated with a high failure rate of up to 50 leading to complications including back pain and epidural hematoma diagnostic delay and increased healthcare costs The success rate has been improved with ultrasound guided LP but the use of ultrasound-guided LP has not been widespread due to inadequate training in ultrasound use and the inability to translate information derived from ultrasonography to the LP procedure uSINE-PAMS was designed to address these challenges uSINE is a machine-learning software to aid the operators in ultrasound-guided LP PAMS is a two-part hardware to translate data from ultrasound to accurate needle insertion and angulation
This study consists of a pilot phase to test the usability of uSINE-PAMs and allow for improvement in technology and clinical workflow for uSINE-PAMS In the pilot phase experienced NNI clinicians who have participated in a previous healthy volunteer study and have been trained to use uSINE will be the operators performing the uSINE-PAMS-guided lumbar puncture During and upon completion of the study challenges in the use of uSINE and PAMS to conduct LP as well as in the implementation of uSINE-PAMS in the clinical workflow will be determined and addressed prior to the main study open-label single-arm phase 2 clinical trial Ten patients will be recruited in this pilot phase
Following the pilot phase an open-label single-arm phase 2 clinical trial to test the effectiveness of uSINE-PAMS-guided LP against historical data of 55 from traditional landmark-based method 50 patients who are planned for LP will be recruited to undergo LP using the uSINE-PAMS-guided technique The overall hypothesis is that uSINE-PAMS-guided LP will achieve at least 20 improvement in first pass success rate of obtaining cerebrospinal fluid compared to historical data of 55 from traditional landmark-based technique therefore leading to reduction in complication rates
This study consists of a pilot phase to test the usability of uSINE-PAMs and allow for improvement in technology and clinical workflow for uSINE-PAMS In the pilot phase experienced NNI clinicians who have participated in a previous healthy volunteer study and have been trained to use uSINE will be the operators performing the uSINE-PAMS-guided lumbar puncture During and upon completion of the study challenges in the use of uSINE and PAMS to conduct LP as well as in the implementation of uSINE-PAMS in the clinical workflow will be determined and addressed prior to the main study open-label single-arm phase 2 clinical trial Ten patients will be recruited in this pilot phase
Following the pilot phase an open-label single-arm phase 2 clinical trial to test the effectiveness of uSINE-PAMS-guided LP against historical data of 55 from traditional landmark-based method 50 patients who are planned for LP will be recruited to undergo LP using the uSINE-PAMS-guided technique The overall hypothesis is that uSINE-PAMS-guided LP will achieve at least 20 improvement in first pass success rate of obtaining cerebrospinal fluid compared to historical data of 55 from traditional landmark-based technique therefore leading to reduction in complication rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None