A Single-Use Duodenoscope in a Real-World Setting


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is ≥ 18 years old.
  • Subject is indicated and scheduled for an elective, non-emergent ERCP.
  • Subject is willing and able to give informed consent and HIPAA authorization.

Exclusion Criteria:

  • Subject has altered pancreaticobiliary anatomy including:
  • Billroth II;
  • Roux-en-Y gastric bypass;
  • Loop gastric bypass;
  • Post-Whipple;
  • Roux-en-Y hepaticojejunostomy.
  • Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
  • Subject has one or more of the following severe co-morbid conditions:
  • Morbid obesity (BMI ≥ 40);
  • Unstable cardiopulmonary conditions;
  • Severe and uncorrectable coagulopathy;
  • Severe and uncorrectable thrombocytopenia.
  • Subject has clinically significant esophageal, pyloric or duodenal strictures.
  • Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
  • Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
  • Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Bret Petersen, M.D.

Closed for enrollment

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