SpyGlass AMEA Registry

Boston Scientific Corporation526 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

526

Conditions

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

Interventions

ERCP (Endoscopic Retrograde Cholangiopancreatography)PROCEDURE

ERCP procedure will be performed to visualize bile ducts.

SpyGlass DVS and SpyGlass Digital Simple (DS)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Royal Adelaide Hospital

Adelaide, Australia

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: Procedure - the average expected duration of the procedure is 1.5 hours

Secondary Outcomes

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.

Time frame: Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit

Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.