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Keep this study
Lead
Ambu A/S
With
Ambu Inc.
Infinite Clinical Solutions
Prelude Dynamics
This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Subject is ≥ 18 years old.
2. Subject is indicated and scheduled for an elective, non-emergent ERCP.
3. Subject is willing and able to give informed consent and HIPAA authorization.
You may not be if
1. Subject has altered pancreaticobiliary anatomy including:
1. Billroth II
2. Roux-en-Y gastric bypass
3. Loop gastric bypass
4. Post-Whipple
5. Roux-en-Y hepaticojejunostomy
2. Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
3. Subject has any of the following severe co-morbid conditions
1. Morbid obesity (BMI ≥ 40)
2. Unstable cardiopulmonary conditions
3. Severe and uncorrectable coagulopathy
4. Severe and uncorrectable thrombocytopenia
4. Subject has clinically significant esophageal, pyloric or duodenal strictures.
5. Subject has been previously been treated under this investigational plan.
6. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
7. Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
8. 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.
Clareo Health | A Single-Use Duodenoscope in a Real-World Setting
