Initial Case Series With Exalt Single-Use Duodenoscope

Study Overview
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Brief Summary
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To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

Detailed Description
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This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 7 days after their procedure.

Official Title
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Initial Case Series With Exalt Single-Use Duodenoscope

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 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exalt DScope 01<br>Subjects will have a clinically indicated per standard of care ERCP 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 ERCP 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 |
| --- | --- | --- |
| Successful 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 qualitative rating | Endoscopist rating of the Exalt single-use duodenoscope compared to their past experience with marketed reusable duodenoscopes as it pertains to various design and performance related attributes. | Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1). | 
| Incidence of 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. | Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1). | 
| Evaluation of adverse events (SAEs) related to the device and/or the procedure |  | SAEs are assessed through 7 days after the procedure. |