SpyGlass AMEA Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Indeterminate strictures or undefined filling defects
|
Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
Device: SpyGlass DVS and SpyGlass Digital Simple (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
|
| Biliary stone cases
|
Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
Device: SpyGlass DVS and SpyGlass Digital Simple (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
|
| Other indications
|
Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.
Device: SpyGlass DVS and SpyGlass Digital Simple (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
|
Outcome Measures
Primary Outcome Measures
- 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 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.
- 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.
Secondary Outcome Measures
- 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.
- 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. [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.
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Brisbane and Women's Hospital | Herston | Queensland | Australia | 4029 |
| 2 | Royal Adelaide Hospital | Adelaide | Australia | ||
| 3 | Royal Prince Alfred Hospital | Newtown | Australia | ||
| 4 | Prince of Wales Hospital | Shatin | Hong Kong | ||
| 5 | Apollo Gleneagles Hospitals Kolkata | Kolkata | West Bengal | India | 70054 |
| 6 | Postgraduate Institute of Medical Education & Research | Chandigarh | India | ||
| 7 | Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences | Gurgaon | India | ||
| 8 | Asian Institute of Gastroenterology | Hyderabad | India | ||
| 9 | Baldota Institute of Digestive Sciences | Parel | India | 400012 | |
| 10 | Teikyo University Mizonokuchi Hospital | Kawasaki | Japan | ||
| 11 | Kinki University School of Medicine | Osaka-sayama | Japan | ||
| 12 | Tokyo Medical University | Tokyo | Japan | ||
| 13 | Soon Chun Hyang University Bucheon Hospital | Bucheon | Korea, Republic of | ||
| 14 | Asan Medical Center | Seoul | Korea, Republic of | ||
| 15 | Samsung Medical Center | Seoul | Korea, Republic of | ||
| 16 | Civil Hospital- Karachi | Karachi | Pakistan | ||
| 17 | King Khalid University Hospital | Riyadh | Saudi Arabia | ||
| 18 | Changi General Hospital Pte Ltd. | Singapore | Singapore | ||
| 19 | Netcare Unitas Hospital | Centurion | South Africa | ||
| 20 | King Chulalongkorn Memorial Hospital | Bangkok | Thailand | 10330 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Benedict Devereaux, Royal Brisbane and Women's Hospital
- Principal Investigator: James Lau, Prince of Wales Hospital
- Principal Investigator: Randhir Sud, Institute of Digestive & Hepatobiliary Sciences
- Principal Investigator: Saad Niaz, Civil Hospital- Karachi
- Principal Investigator: Abdulrahman Aljebreen, King Khalid University Hospital
- Principal Investigator: Ang Tiing Leong, Changi General Hospital Pte Ltd.
- Principal Investigator: Jorg Reichenberger, Netcare Unitas Hospital
- Principal Investigator: Jong Moon, Soon Chun Hyang University
- Principal Investigator: Rungsun Rerknimitr, King Chulalongkorn Memorial Hospital
- Principal Investigator: Ichiro Yasuda, Teikyo University Mizonokuchi Hospital
- Principal Investigator: Arthur J. Kaffes, Royal Prince Alfred Hospital, Sydney, Australia
- Principal Investigator: Nam Q. Nguyen, Royal Adelaide Hospital
- Principal Investigator: Amit Maydeo, Baldota Institute of Digestive Sciences
- Principal Investigator: Mohan Ramchandani, Asian Institute of Gastroenterology
- Principal Investigator: Mahesh Goenka, Apollo Gleneagles Hospital
- Principal Investigator: Professor R. Kochhar, Postgraduate Institute of Medical Education & Research
- Principal Investigator: Takao Itoi, Tokyo Medical University
- Principal Investigator: Masayuki Kitano, Kinki University School of Medicine
- Principal Investigator: Jong K. Lee, Samsung Medical Center
- Principal Investigator: Dongwan Seo, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 90947376