SpyGlass AMEA Registry

Completed

• Conditions: Biliary Stricture; Biliary Obstruction Due to Common Bile Duct Stone; Hemobilia; Periampullary Tumor
• Interventions: Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography); Device: SpyGlass DVS and SpyGlass Digital Simple (DS)

• Registration Number: NCT02281019
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-02
• Study Start: 2014-11-15
• Primary Completion: 2016-09
• Study Completion: 2016-10-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 526

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biliary stone cases	SpyGlass DVS and SpyGlass Digital Simple (DS)	-
Other indications	ERCP (Endoscopic Retrograde Cholangiopancreatography)	-
Biliary stone cases	ERCP (Endoscopic Retrograde Cholangiopancreatography)	-
Indeterminate strictures or undefined filling defects	ERCP (Endoscopic Retrograde Cholangiopancreatography)	-
Indeterminate strictures or undefined filling defects	SpyGlass DVS and SpyGlass Digital Simple (DS)	-
Other indications	SpyGlass DVS and SpyGlass Digital Simple (DS)	-

Primary Outcome Measures

Name	Time	Method
Procedural success for indeterminate strictures or undefined filling defects	Procedure - the average expected duration of the procedure is 1.5 hours	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
Procedural success for other indications	Procedure - the average expected duration of the procedure is 1.5 hours	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.
Procedural success for biliary stone cases	Procedure - the average expected duration of the procedure is 1.5 hours	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.

Secondary Outcome Measures

Name	Time	Method
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.	Procedure to 6 months	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.
Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP	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
Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure	Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit	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.
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

Trial Locations

Locations (20)

Apollo Gleneagles Hospitals Kolkata; 🇮🇳 Kolkata, West Bengal, India

Royal Prince Alfred Hospital; 🇦🇺 Newtown, Australia

Changi General Hospital Pte Ltd.; 🇸🇬 Singapore, Singapore

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences; 🇮🇳 Gurgaon, India

Baldota Institute of Digestive Sciences; 🇮🇳 Parel, India

Civil Hospital- Karachi; 🇵🇰 Karachi, Pakistan

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, India

Teikyo University Mizonokuchi Hospital; 🇯🇵 Kawasaki, Japan

Kinki University School of Medicine; 🇯🇵 Osaka-sayama, Japan

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Postgraduate Institute of Medical Education & Research; 🇮🇳 Chandigarh, India

Tokyo Medical University; 🇯🇵 Tokyo, Japan

King Khalid University Hospital; 🇸🇦 Riyadh, Saudi Arabia

Netcare Unitas Hospital; 🇿🇦 Centurion, South Africa

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong