SBIR-STTR Award

Endoscopic retrograde cholangiopancreatography (ERCP) has one of the highest complication rates of all gastrointestinal endoscopic procedures. Morbidity has been reported to be 7-10% and mortality as high as 1.2%. It is technically difficult to learn and requires a large number of procedures to become competent. During the proposed research HT Medical will develop a virtual reality ERCP simulation system that allows trainees to learn and practice this procedure prior to actual patient contact. This offers the potential to improve patient care, decrease costs, and provide objective measurement of procedural competence. During Phase I a prototype simulator that emphasizes diagnostic ERCP will be developed and evaluated by gastrointestinal endoscopists. In Phase II of this project, the prototype simulator will be advanced to included therapeutic ERCP procedures. Visual and tactile enhancements that are necessary for commercialization will be made based on the evaluation of the endoscopists. A more comprehensive study will be conducted to evaluate the training efficacy of the simulator. During Phase II we will target medical schools, physician training programs, medical device companies, and CME organizations. The market base will be expanded by other medical simulators, using technology developed for the ERCP simulator. PROPOSED COMMERCIAL APPLICATION: There is a significant need for improved endoscopic training and no products currently exist that meet this need. The virtual reality simulator would be used to train physicians to perform ERCP. The target market includes medical schools, physician training programs, medical device companies, and organizations and hospitals that teach Continuing Medical Education courses. We plan on capturing an even larger market by leveraging the technology developed for the ERCP simulator to produce other medical simulators.

Thesaurus Terms:
cholangiography, computer assisted instruction, computer simulation, computer system design /evaluation, education evaluation /planning, medical education, pancreas visualization fluoroscopy, interactive multimedia, training aid human data

This revised Phase II proposal describes the development of three simulation modules for training n therapeutic endoscopic retrograde cholangiopancreatography (ERCP): sphincterotomy, stone extraction, and stenting. The proposed work builds on a recently completed prototype simulator for diagnostic ERCP. A completed procedure description will be used to formulate a task analysis, from which we will develop didactic content and module layout. The proposed hardware focus on developing a tri-coaxial tracking system that provides haptics in translational and rotational axes, and simulating working channel force feedback associated with therapeutic tools. Therapeutic modules will require new organ and tissue models and renderings to represent various pathologies, case histories, and interventions. We also describe a more sophisticated model of fluid dynamics to simulate certain therapeutic manipulations, a particle-based system for simulating papillary changes during sphincterotomy, a standard electrical conductivity model for electrocautery, rigid body equations for stone dynamics, and a system of pre-defined fracture planes to simulate lithography. Clinical experts will provide formative evaluations, and a construct validity study will test whether the simulator can discriminate among experts, intermediates, and novices.

Thesaurus Terms:
cholangiography, computer assisted instruction, computer simulation, computer system design /evaluation, education evaluation /planning, endoscopy, medical education, pancreas imaging /visualization computer program /software, fluid flow, fluoroscopy, interactive multimedia, training aid clinical research, human subject