Overview

This trial is active, not recruiting.

Conditions biliary stricture, biliary obstruction due to common bile duct stone, periampullary tumor, hemobilia
Treatments ercp (endoscopic retrograde cholangiopancreatography), spyglass dvs and spyglass ds
Sponsor Boston Scientific Corporation
Start date November 2014
End date September 2016
Trial size 526 participants
Trial identifier NCT02281019, 90947376

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
ercp (endoscopic retrograde cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
spyglass dvs and spyglass ds
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
ercp (endoscopic retrograde cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
spyglass dvs and spyglass ds
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
ercp (endoscopic retrograde cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
spyglass dvs and spyglass ds
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

Primary Outcomes

Measure
Procedural success for indeterminate strictures or undefined filling defects
time frame: Procedure - the average expected duration of the procedure is 1.5 hours
Procedural success for biliary stone cases
time frame: Procedure - the average expected duration of the procedure is 1.5 hours
Procedural success for other indications
time frame: Procedure - the average expected duration of the procedure is 1.5 hours

Secondary Outcomes

Measure
Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure
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
time frame: 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.
time frame: 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.
time frame: Procedure to 6 months
For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.
time frame: 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.
time frame: 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.
time frame: Procedure - the average expected duration of the procedure is 1.5 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
Principal investigator Benedict Devereaux
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.