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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02281019
Other study ID # 90947376
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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