SpyGlass AMEA Registry

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281019
• Other study ID #: 90947376
• Status: Completed
• Start date: November 15, 2014
• Est. completion date: October 18, 2016

Study information

• Verified date: July 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: October 18, 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Royal Prince Alfred Hospital	Newtown
Hong Kong	Prince of Wales Hospital	Shatin
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Medanta -The Medicity Institute of Digestive & Hepatobiliary Sciences	Gurgaon
India	Asian Institute of Gastroenterology	Hyderabad
India	Apollo Gleneagles Hospitals Kolkata	Kolkata	West Bengal
India	Baldota Institute of Digestive Sciences	Parel
Japan	Teikyo University Mizonokuchi Hospital	Kawasaki
Japan	Kinki University School of Medicine	Osaka-sayama
Japan	Tokyo Medical University	Tokyo
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Pakistan	Civil Hospital- Karachi	Karachi
Saudi Arabia	King Khalid University Hospital	Riyadh
Singapore	Changi General Hospital Pte Ltd.	Singapore
South Africa	Netcare Unitas Hospital	Centurion
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  Hong Kong,  India,  Japan,  Korea, Republic of,  Pakistan,  Saudi Arabia,  Singapore,  South Africa,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure - the average expected duration of the procedure is 1.5 hours
Primary	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.	Procedure - the average expected duration of the procedure is 1.5 hours
Primary	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.	Procedure - the average expected duration of the procedure is 1.5 hours
Secondary	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.	Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit
Secondary	Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP		Procedure - the average expected duration of the procedure is 1.5 hours
Secondary	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
Secondary	For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.	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.	Procedure to 6 months
Secondary	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
Secondary	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
Secondary	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