A Single-Use Duodenoscope in a Real-World Setting

Ambu

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Treatments: Device: aScope™ Duodeno endoscope and aBox™ Duodeno

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04628949

CIS-018

Details and patient eligibility

About

This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.

Full description

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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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248 participants in 1 patient group

aScope™ Duodeno endoscope and aBox™ Duodeno

Experimental group

Description:

Eligible subjects who are undergoing non-emergent, clinically indicated ERCP using aScope™ Duodeno endoscope and aBox™ Duodeno.

Treatment:

Device: aScope™ Duodeno endoscope and aBox™ Duodeno