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Trial ID
NCT02281019
Ethics application status
Date submitted
9/10/2014
Date registered
9/10/2014
Date last updated
26/05/2016

Titles & IDs
Public title
SpyGlass AMEA Registry
Scientific title
Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
Secondary ID [1] 0 0
90947376
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary Stricture 0 0
Biliary Obstruction Due to Common Bile Duct Stone 0 0
Periampullary Tumor 0 0
Hemobilia 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: surgery - ERCP (Endoscopic Retrograde Cholangiopancreatography)
Treatment: devices - SpyGlass DVS and SpyGlass DS

Indeterminate strictures or undefined filling defects -

Biliary stone cases -

Other indications -


Treatment: surgery: ERCP (Endoscopic Retrograde Cholangiopancreatography)
ERCP procedure will be performed to visualize bile ducts.

Treatment: devices: 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

Intervention code [1] 0 0
Treatment: surgery
Intervention code [2] 0 0
Treatment: devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit
Secondary outcome [2] 0 0
Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP
Timepoint [2] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours
Secondary outcome [3] 0 0
Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.
Timepoint [3] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Procedure to 6 months
Secondary outcome [5] 0 0
For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.
Timepoint [5] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours
Secondary outcome [6] 0 0
For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session.
Timepoint [6] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours
Secondary outcome [7] 0 0
For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP.
Timepoint [7] 0 0
Procedure - the average expected duration of the procedure is 1.5 hours

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Newtown
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Queensland
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Newtown
Recruitment postcode(s) [3] 0 0
- Queensland
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Shatin
Country [2] 0 0
India
State/province [2] 0 0
Chandigarh
Country [3] 0 0
India
State/province [3] 0 0
Gurgaon
Country [4] 0 0
India
State/province [4] 0 0
Hyderabad
Country [5] 0 0
India
State/province [5] 0 0
Parel
Country [6] 0 0
India
State/province [6] 0 0
West Bengal
Country [7] 0 0
Japan
State/province [7] 0 0
Kawasaki
Country [8] 0 0
Japan
State/province [8] 0 0
Osaka-sayama
Country [9] 0 0
Japan
State/province [9] 0 0
Tokyo
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Bucheon
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Pakistan
State/province [12] 0 0
Karachi
Country [13] 0 0
Saudi Arabia
State/province [13] 0 0
Riyadh
Country [14] 0 0
Singapore
State/province [14] 0 0
Singapore
Country [15] 0 0
South Africa
State/province [15] 0 0
Centurion
Country [16] 0 0
Thailand
State/province [16] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Benedict Devereaux
Address 0 0
Royal Brisbane and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information