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A Biobank for Pancreatic Diseases
Rochester, MN
To develop a resource (bank) of biospecimens and data collected from individuals with pancreatic diseases to facilitate discovery and development of novel biomarkers of risk and early detection, severity prediction, etiology and response to therapy.
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Global Prospective Case Series Using a Single-Use Duodenoscope
Rochester, MN
The purpose of this study is to confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.
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A Study to Establish Initial Case Series with Exalt Single-Use Duodenoscope
Rochester, MN
The purpose of this study is to confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.
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A Single-Use Duodenoscope in a Real-World Setting
Rochester, MN
The primary objective of this trial is to demonstrate the rate of successful ERCP procedure for the intended indication using the aScope™ Duodeno endoscope.
A secondary objective of this trial is to establish comprehensive performance attributes of the aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures, and overall operator satisfaction rates.
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A Quality of Life Assessment of Patients with Biliary Obstruction Undergoing Endoscopic or Percutaneous Drainage
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The aim of this study is to compare the quality of life of patients with biliary obstruction who have undergone an endoscopic or percutaneous drainage. The quality of life of patients witll be assessed using the validated "European Quality of Life-5 Dimensions Questionnaire" and the "Intervention-Dependent Questionnaire" which was developed according to current literature as well as the expert opinion of gastroeneterologists.
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A Study to Compare COVID-19 Nasal Testing to Gastric, Bile, or Intestinal Testing
Rochester, MN
The primary aim of this study is to determine if there is any evidence of viral shedding within the gastrointestinal or pulmonary system in patients with a prior recent negative nasopharyngeal PCR test. This will be of critical importance to the practice of endoscopy during this pandemic as it will help: 1) determine if a pre-endoscopy testing strategy is adequate to ramp-up access to semi-urgent and eventually elective procedures, while allowing the decreased utilization of limited or costly personal protective equipment (e.g., N95 respirators) while still keeping the GI endoscopy staff safe; and 2) realize the false negative rate of pre-procedural testing, which is vital to inform procedural practice policy and operations.