Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories

Will evaluate the effectiveness of digital cholangioscopy (DC) in guiding fragmentation of difficult biliary stones. Will examine the efficacy of the intraductal lithotripsy procedure utilizing electrohydraulic lithotripsy in achieving biliary stone fragmentation and complete bile duct stone clearance among patients who have failed conventional stone extraction techniques. Stone fragmentation and complete ductal clearance will be assessed using descriptive statistics with interquartile range (IQR) for the number of procedures to achieve clearance at index or subsequent procedures. Ninety-five percent confidence intervals will be provided for descriptive statistics.

Will evaluate the ability of the DC to deliver tools to obtain adequate tissue samples (biopsies) to be analyzed for the presence or absence of disease, including cancer, infection, or other conditions in subjects with indeterminate strictures. Will use descriptive analysis with sensitivity, specificity, accuracy, median and IQR plus operating characteristics of visualization and sampling in those patients with indeterminate strictures. Will evaluate the diagnostic efficacy of the novel biopsy forceps in the context of indeterminate biliary strictures and provide robust evidence for clinical decision-making.

Will evaluate the total procedure time for bile duct stones.

Will evaluate the number of procedures required to achieve bile duct stone clearance after referral. Will summarize with descriptive statistics and report success rates. Ninety-five percent confidence intervals will be provided for descriptive statistics.

Will assess whether the DPS functioned as intended in combination with the commercially available accessories. Functioned as intended is defined as the ability to set up, provide visualization, deliver the accessory to the target location, use of the accessory according to the instructions for use. Will summarize with descriptive statistics and report success rates.

Will evaluate ergonomics by collecting anthropometric data from physician users. Will provide product performance evaluation data.

Will evaluate lithotripsy fragmentation time for bile duct stones. Will summarize with descriptive statistics and report success rates.

Will evaluate product performance for indeterminate biliary strictures as rated by the endoscopist operating the DPS system. Will summarize with descriptive statistics and report success rates.

Will assess usability by the System Usability Scale. Will provide product performance evaluation data.

Will evaluate the ability to adequately visualize biliary strictures, including the presence of both neoplastic (irregular nodular mucosa, irregular papillary projections, intraductal or villous mass, dilated and tortuous vessels with branching, infiltrative stricture, ulceration, and contact friability/ease of oozing) and benign (concentric, bandlike scar, uniform projections, thin vessels) characteristics. Will summarize with descriptive statistics and report success rates.

Will evaluate usability by the ability to visualize stone or stricture characteristics as rated by the endoscopist operating the DPS system.

Will assess user satisfaction with the Net Promoter Score. Will provide product performance evaluation data.

Will evaluate usability by the ability to pass the lithotripsy device and/or stone removal device to the target area as rated by the endoscopist operating the DPS system.

Will assess the subjective assessment of work by the National Aeronautics and Space Administration-Task

Will evaluate the bile duct stone recurrence rate. Will summarize with descriptive statistics and report success rates.