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SpyGlass AMEA Registry | Clinical Trials | Clareo Health

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SpyGlass AMEA Registry

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

NCT02281019•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Royal Prince Alfred Hospital

Newtown, Australia

Prince of Wales Hospital

Shatin, Hong Kong

Apollo Gleneagles Hospitals Kolkata

Kolkata, West Bengal, India

Postgraduate Institute of Medical Education & Research

Chandigarh, India

Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences

Gūrgaon, India

Asian Institute of Gastroenterology

Hyderabad, India

Baldota Institute of Digestive Sciences

Pārel, India

Teikyo University Mizonokuchi Hospital

Kawasaki, Japan

Key Dates

Start Date

November 15, 2014

Primary Completion Date

September 1, 2016

Completion Date

October 18, 2016

Last Updated

July 10, 2019

Enrollment

526

ACTUAL participants

Conditions

Biliary StrictureBiliary Obstruction Due to Common Bile Duct StonePeriampullary TumorHemobilia

Interventions

ERCP (Endoscopic Retrograde Cholangiopancreatography)

PROCEDURE

SpyGlass DVS and SpyGlass Digital Simple (DS)

DEVICE

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

NCT07407491

Acute CholangitisBiliary Tract Infection+3 more

View study

RECRUITINGNA

Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis

NCT06655051

Chronic PancreatitisBenign Biliary Stricture

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SpyGlass AMEA Registry

Inclusion Criteria

Exclusion Criteria

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis

Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis

Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study

Prospective Evaluation of Biliary Tissue Sampling with ERCP

MicroRNAs as Bile-based Biomarkers in Pancreaticobiliary Cancers