Phase I Amount
$1,032,828
Over 450,000 diagnostic lumbar punctures (LPs) are performed annually in the US, but up to 15 - 35% end in procedural failure, primarily due to inability to access the intrathecal space. Bedside LP failure rates are particularly high in the growing obese population, with recent studies reporting failure rates greater than 50% in subjects over BMI 35 kg/m2. Given its technical difficulty, there is a reluctance to perform bedside LPs, even when medically indicated. Consequently, 30 - 50% of LPs are now performed under fluoroscopic guidance, but securing neuroradiology services delays diagnosis, adds cost, and is not possible in emergency or critical care situations. The total direct and indirect costs of failed LPs to patients and the healthcare system exceed $500M/yr. Thus, there is a clear need for bedside LPs to reach success rates similar to those performed using fluoroscopy, and it is likely that a technological advancement that reduces the difficulty of administering LPs is required to meet this need. During this project, a 3D ultrasound-based bedside LP guidance system will be developed under a quality management system (QMS) certified to ISO 13485:2016 and 21 CFR Part 820. The key technological innovations underpinning the development of this product include the following: 3D bone reconstruction technologies enabling "˜fluoroscopy-like' renderings of the lumbar spine, spine landmark recognition algorithms that automatically detect the location of the intrathecal space, and needle guidance methods to aid visualization of the needle trajectory. The primary technical tasks during the early phases of the project period include the execution of end-user clinical usability studies to guide technical specification development, electro- mechanical sub-system design, integration, and validation, and design and implementation of core ultrasound imaging processing and visualization algorithms. Successful completion of these technical aims will result in fabrication of pre-production systems for pre-clinical validation studies later in the project period. Pre-clinical product validation activities will include cadaver and human-imaging studies performed in collaboration with clinical experts who will validate that the system meets the requirements for the clinical application. The primary endpoint for the pre-clinical cadaveric studies is a direct comparison of needle placement accuracy between the current standard of care (blind needle placement) and the 3D-ultrasound needle guidance product. An additional pre-clinical study will characterize overall system usability and the learning curve required to reach competency with the system by studying the product's use in 150 simulated imaging procedures, performed by at least 10 individual neurologists. Completion of this research project will result in the development and fabrication of a human clinical-trial- ready 3D-imaging based lumbar puncture guidance system.
Public Health Relevance Statement: PROJECT NARRATIVE Lumbar puncture performed at the patient bedside is the mainstay for cerebrospinal fluid sampling during the diagnosis and management of many inflammatory and degenerative neurological disorders. Procedural failures occur in approximately 15 - 35 % of all cases, and in over 50 % of lumbar punctures performed in obese subjects, due to the inability to access the subarachnoid space during needle placement - a problem that results in delayed treatment and diagnosis, increased risk of associated complications, and additional costs to the patient and healthcare system. The goal of this project is to evaluate the efficacy of an ultrasound-based bedside lumbar puncture guidance system that facilitates real-time needle guidance, improves procedural success rates, and lowers the risk of complications.
Project Terms: Adoption; Algorithms; Ambulatory Care Facilities; Outpatient Clinics; Anatomy; Anatomic; Anatomic Sites; Anatomic structures; Anatomical Sciences; bone; Cadaver; Cerebrospinal Fluid; cerebral spinal fluid; spinal fluid; Clinical Trials; Critical Care; Diagnosis; Exhibits; Feedback; Fluoroscopy; Goals; Growth; Generalized Growth; Tissue Growth; ontogeny; Hand; Healthcare Systems; Health Care Systems; Hospitals; Human; Modern Man; Learning; Medical Device; Methods; Motion; Needles; Neurology; Obesity; adiposity; corpulence; Patients; Physicians; Production; Radiology Specialty; General Radiology; Radiology; Real-Time Systems; realtime systems; Residencies; Resources; Research Resources; Risk; Sensitivity and Specificity; Spinal Puncture; Lumbar Puncture; Vertebral column; Spinal Column; Spine; backbone; Subarachnoid Space; Supervision; Technology; Time; Training Programs; Ultrasonography; Echography; Echotomography; Medical Ultrasound; Ultrasonic Imaging; Ultrasonogram; Ultrasound Diagnosis; Ultrasound Medical Imaging; Ultrasound Test; diagnostic ultrasound; sonogram; sonography; sound measurement; ultrasound; ultrasound imaging; ultrasound scanning; Work; Imaging Techniques; Imaging Procedures; Imaging Technics; Health Care Costs; Health Costs; Healthcare Costs; Competence; base; image processing; improved; Procedures; Image Analysis; Image Analyses; image evaluation; image interpretation; bone imaging; bone scanning; skeletal imaging; Site; Acute; Clinical; Phase; Medical; Training; Failure; Intuition; Individual; Neurologist; Funding; Research Project Grants; R-Series Research Projects; R01 Mechanism; R01 Program; Research Grants; Research Projects; Collaborations; Inflammatory; Diagnostic; Research Specimen; Specimen; mechanical; Mechanics; Techniques; System; 3-D; 3D; three dimensional; 3-Dimensional; Location; Spinal; Degenerative Neurologic Diseases; Degenerative Neurologic Disorders; Nervous System Degenerative Diseases; Neural Degenerative Diseases; Neural degenerative Disorders; Neurodegenerative Diseases; Neurologic Degenerative Conditions; degenerative diseases of motor and sensory neurons; degenerative neurological diseases; neurodegenerative illness; Neurodegenerative Disorders; Services; success; sterile; Sterility; skills; validation studies; technological innovation; Modality; Reporting; Position; Positioning Attribute; Sampling; 3-D Imaging; 3D imaging; Three-Dimensional Imaging; Manufacturer; Manufacturer Name; BMI; BMI percentile; BMI z-score; Quetelet index; Body mass index; Intrathecal Space; Data; Detection; Direct Costs; International; in vivo; Facilities and Administrative Costs; Indirect Costs; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; Validation; Development; developmental; Emergency Care; ED care; ER care; Emergency Department care; Emergency Room care; Emergency health care; Emergency healthcare; Emergency medical care; Image; imaging; pre-clinical; preclinical; preclinical study; pre-clinical study; cost; imaging probe; reconstruction; image visualization; design; designing; efficacy evaluation; efficacy analysis; efficacy assessment; efficacy examination; evaluate efficacy; examine efficacy; blind; Imaging technology; Navigation System; clinical application; clinical applicability; usability; stem; commercial application; commercialization; aging population; aged population; population aging; patient population; standard of care; product development; disease diagnosis; Secure; arm; image guided; image guidance; imaging platform; imaging system; 3D ultrasound; 3-D ultrasound; human imaging; preclinical development; pre-clinical development; imaging study; primary endpoint; primary end point; Visualization; automated algorithm; automatic algorithm; obese person; obese individuals; obese people; obese population; obese subjects; obese patients; patients with obesity
