A Single-Use Duodenoscope in a Real-World Setting
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-009212
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 |
|
More information
Publications
Publications are currently not available