Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conditions
Keywords
Endoscopic Retrograde Cholangiopancreatography, ERCP, Duodenoscope, Endoscope, aScope Duodeno, aBox
Brief summary
This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.
Detailed 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.
Interventions
DEVICEaScope™ Duodeno endoscope and aBox™ Duodeno
The aScope™ Duodeno endoscope is a sterile single-use disposable duodenoscope indicated for endoscopic retrograde cholangiopancreatography (ERCP) procedures.The aScope™ Duodeno endoscope is designed to be used with aBox Duodeno, endoscopic accessories and other ancillary equipment for ERCP procedures. The aBox Duodeno is the console that is necessary for processing the endoscope camera´s video image, regarding the remote switches and output video and recorder data. The aBox Duodeno is designed to be used with the aScope™ Duodeno endoscope.
Sponsors
Ambu Inc.
Infinite Clinical Solutions
Prelude Dynamics
Ambu A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Non-Randomized, Single-Arm, Post-Market Observational Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s). | Procedure Completion (Day 0) | Procedure success will be defined as the successful completion of the ERCP procedure with the aScope™ Duodeno endoscope. The procedural success rate will be the incidence rate of success for the ERCP procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures. | Procedure Completion (Day 0) | Procedure success for sub categories of ERCP procedures will be defined as the successful completion of the ERCP procedure with the aScope™ Duodeno endoscope. The procedural success rate will be the incidence rate of success for the stratified sub-categories of ERCP procedures with the the aScope™ Duodeno endoscope. |
| To evaluate rate of conversion to a reusable endoscope, other endoscope or an open procedure from the aScope™ Duodeno endoscope during the ERCP procedure. | Procedure Completion (Day 0) | Rate of conversion will be measured by the incidence rate of when a conversion to a different endoscope or open procedure is necessitated during the ERCP procedure with the aScope™ Duodeno endoscope. |
| To evaluate the device deficiency rate for the aScope™ Duodeno endoscope. | Procedure Completion (Day 0) | Incidence rate of device deficiencies as defined as either a device failure or device malfunction for the aScope™ Duodeno endoscope during ERCP procedure. |
| To evaluate physician satisfaction with the aScope™ Duodeno endoscope. | Procedure Completion (Day 0) | Physician reported outcomes questionnaire on physician satisfaction with the aScope™ Duodeno endoscope for ERCP procedures. |
| To evaluate rate of successful completion of a converted ERCP procedure. | Procedure Completion (Day 0) | Successful completion will be measured by the incidence rate of success for converted ERCP procedure as stratified by the conversion method (reusable scope, other endoscope, other procedure). |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate safety of the aScope™ Duodeno endoscope in ERCP. | Day 30 (+3) Post-Procedure | Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure. |
Countries
United States
Outcome results
None listed