Exalt D Single-use Duodenoscope in ERCP Procedures in China

Study Overview
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Brief Summary
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Study Objective(s)：This study is to evaluate the feasibility, preliminary safety and performance of Exalt D Single-use Duodenoscope in ERCP procedures in China, to generate local real world data from a Chinese ERCP population. Study Design：Prospective, single-arm study Planned Number of Subjects：Up to 35 to satisfy 30 treated cohort Primary Endpoint：Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope. It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D).

Detailed Description
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Device Description：The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an Exalt™ Controller. The Exalt™ Controller is an electronic device that: Receives video signals from a Boston Scientific single-use endoscope, Processes the video signals, Outputs video images to a video monitor, and Outputs electrical signal(s) that interface with external image capture systems. Study Design：This is a prospective, single-arm study with up to 35 subjects to satisfy 30 treated cohort in up to 3 centers. The study duration is expected to be approximately 7 months, assuming 6 months enrollment and 1 month follow up. The study duration for each subject is expected to be approximately 30 days. Data Analyses：All statistical analyses will be done using The SAS System software, version 8 or higher (Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, USA. All rights reserved).

Official Title
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Real World Study of Exalt D Single-use Duodenoscope in ERCP Procedures in China

Conditions
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Cholangiopancreatography

Intervention / Treatment
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* Device: ExaltTM 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 Schedule for a clinically indicated ERCP Exclusion Criteria: Potentially vulnerable subjects, including, but not limited to pregnant women Subjects for whom endoscopic techniques are contraindicated Subjects 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm study<br>A single-arm of 30 treated patients is appropriate to generate additional local data on Exalt D Single-use Duodenoscope, since there is existing information in the previous study of Exalt D Single-use Duodenoscope in ERCP procedures and clinical literature regarding its performance. | Device: ExaltTM Model D Single-Use Duodenoscope<br>* The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an Exalt™ Controller.<br>* Other names: ExaltTM Controller;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients complete the ERCP procedure | Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope. It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D). | During the procedure | 

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. Besides those criteria similar to Exalt DScope 01 study, assessment in this study will include imaging quality (brightness, color, photometry), overall maneuverability and overall satisfaction, which will be rated from 1-10, where 1 is the worst and 10 is the best. | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP