Single-use duodenoscopes for the prevention of endoscopic retrograde cholangiopancreatography -related cross-infection – from bench studies to clinical evidence

Table 2 Summary of ongoing registered studies assessing the performance of single-use duodenoscope for American society for gastrointestinal endoscopy, registered on clinicaltrial.gov portal

Title, reference	Region	Investigators	Design, population, Duodenoscope	Primary outcome	Status
Single Use ERCP -SURE Study (SURE). NCT04671095	Nottingham, United Kingdom	Dr. Suresh Vasan Venkatachalapathy; suresh.venkatachalapathy@nuh.nhs.uk	Prospective, 50 patients, EXALT-D1	Technical success (ERCP completion)	Not yet recruiting
International Study to Evaluate Outcomes and Safety of Patients Undergoing ERCP Using a Single-use Cholangioscope and Single-use Duodenoscope (MESE). NCT04712253	Rozzano (MI), Italy	Prof. Alessandro Repici alessandro.repici@hunimed.eu; Dr. Andrea Anderloni andrea.anderloni@humanitas.it	Retrospective, 50 patients, EXALT-D1	Technical success, clinical outcomes	Recruiting
Global Prospective Case Series Using a Single-Use Duodenoscope. NCT04103749	United States	Gregory Tirrell; gregory.tirrell@bsci.com; Pooja Goswamy; pooja.goswamy@bsci.com	Prospective, 1000 patients, EXALT-D1	Technical success (ERCP completion)	Not yet recruiting
Exalt D Single-use Duodenoscope in ERCP Procedures in China (ExaltDScope). NCT04687774	China	Zhiwei Guzhiwei.gu@bsci.com; Jingjing Gu	Observational, 30 patients, EXALT-D1	Technical success (ERCP completion)	Not yet recruiting
A Single-Use Duodenoscope in a Real-World Setting. NCT04628949	United States	Elizabeth Smith; elsm@ambu.comTrine; Højgaard Tølbøll; trht@ambu.com	Prospective, 550 patients, aScope	Technical success (ERCP completion)	Recruiting

¹EXALT-D is manufactured by Boston Scientific (MA, United States). The aScope™ Duodeno is manufactured by Ambu A/S (Denmark). ASGE: American Society for Gastrointestinal Endoscopy.