Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

Study Overview
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Brief Summary
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The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.

Detailed Description
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The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.

Official Title
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Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

Conditions
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Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Device: Exalt Model D Single-Use Duodenoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Willing and able to comply with the study procedures and provide written informed consent to participate in the study Scheduled for a clinically indicated endoscopic retrograde cholangiopancreatography (ERCP) Exclusion Criteria: Altered pancreaticobiliary anatomy Potentially vulnerable subjects, including, but not limited to pregnant women Subjects for whom endoscopic techniques are contraindicated Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor Investigator discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exalt DScope 01B<br>Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. | Device: Exalt Model D Single-Use Duodenoscope<br>* Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure | The ability to complete the ERCP procedure for the intended indication(s); outcome reported as success or failure. Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones. | Procedure success is assessed at the end of the procedure (within 24 hours on study day 1). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope | Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. | Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1. | 
| Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope | The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover. | Crossover is monitored throughout the procedure (within 24 hours on study day 1). | 
| Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure | Number of serious adverse events (SAEs) related to the device and/or the procedure. | SAEs are assessed through 7 days after the procedure. |