SpyGlass AMEA Registry

Study Overview
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Brief Summary
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The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

Official Title
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Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region

Conditions
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Biliary Stricture, Biliary Obstruction Due to Common Bile Duct Stone, Periampullary Tumor, Hemobilia

Intervention / Treatment
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* Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
* Device: SpyGlass DVS and SpyGlass Digital Simple (DS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older. Willing and able to provide written informed consent to participate in the study. Willing and able to comply with the study procedures. Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy. Exclusion Criteria: Endoscopic techniques are contraindicated. ERCP is contraindicated A medical condition that warrants the use of the device outside of the indication for use. Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indeterminate strictures or undefined filling defects<br> | Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)<br>* ERCP procedure will be performed to visualize bile ducts.<br>Device: SpyGlass DVS and SpyGlass Digital Simple (DS)<br>* Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed<br>|
| Biliary stone cases<br> | Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)<br>* ERCP procedure will be performed to visualize bile ducts.<br>Device: SpyGlass DVS and SpyGlass Digital Simple (DS)<br>* Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed<br>|
| Other indications<br> | Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)<br>* ERCP procedure will be performed to visualize bile ducts.<br>Device: SpyGlass DVS and SpyGlass Digital Simple (DS)<br>* Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success for indeterminate strictures or undefined filling defects | For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology | Procedure - the average expected duration of the procedure is 1.5 hours | 
| Procedural success for biliary stone cases | For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures. | Procedure - the average expected duration of the procedure is 1.5 hours | 
| Procedural success for other indications | For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other. | Procedure - the average expected duration of the procedure is 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure | Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit. | Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit | 
| Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP |  | Procedure - the average expected duration of the procedure is 1.5 hours | 
| Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure. |  | Procedure - the average expected duration of the procedure is 1.5 hours | 
| For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies. | Assessment Detail: Endpoint determined for all patients in whom SpyBite biopsy was taken and observed image features were reported. Observed image features include the following categories: None, Growth, Stricture, Hyperplasia, Ulceration, Mass, Dilated tortuous vessels, Papillary or villous projections, Intraductal nodules, Mucus. | Procedure to 6 months | 
| For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance. |  | Procedure - the average expected duration of the procedure is 1.5 hours | 
| For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session. |  | Procedure - the average expected duration of the procedure is 1.5 hours | 
| For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP. |  | Procedure - the average expected duration of the procedure is 1.5 hours |