Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
  • Duodenoscope maneuverability [ Time Frame: Maneuverability will be assessed only during the procedure (approximately 10 minutes) ]

    Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for its maneuverability during the procedure using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver(1).

  • Duodenoscope mechanical characteristics profile [ Time Frame: Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes) ]

    Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their mechanical characteristics (scope stiffness, air-water button functionality, elevator efficiency and hand strain). Each characteristic will be assessed using a published 5-point scoring system.

  • Duodenoscope imaging characteristics profile [ Time Frame: Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes) ]

    Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their imaging characteristics (image quality and stability). Each characteristic will be assessed using a published 5-point scoring system.

  • Ability to perform interventions [ Time Frame: 30-60 minutes ]

    Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy. Each patient’s procedure will be assessed on a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

  • Source: View full study details on ClinicalTrials.gov

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    October 26, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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