Clinical Registry using the SpyGlassâ?¢ Direct Visualization System to document indications for cholangioscopy and clinical utility throughout the Asia, Middle-East, Africa region when used per standard of practice

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/11/005173
• Date of registration: 05-11-2014
• Prospective Registration: Yes
• Primary sponsor: Boston Scientific Corporation
• Public title: Clinical Registry using the SpyGlassâ?¢ Direct Visualization System to document indications for cholangioscopy and clinical utility throughout the Asia, Middle-East, Africa region when used per standard of practice
• Scientific title: Clinical Registry of Cholangioscopy Using the SpyGlassâ?¢ Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) Region
• Date of first enrolment: 15-11-2014
• Target sample size: 500
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9896
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 4

Countries of recruitment

Australia, Hong Kong, India, Japan, Pakistan, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand

Contacts

• Name: Dr Mohan Ramchandani
• Affiliation: Asian Institute of Gastroenterology

• Name: Dr Mohan Ramchandani
• Affiliation: Asian Institute of Gastroenterology

Key inclusion & exclusion criteria

Inclusion criteria: 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: 1.Endoscopic techniques are contraindicated.

2.ERCP is contraindicated

3.A medical condition that warrants the use of the device outside of the indication for use.

4.Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 2: null- Patients with very different distribution of bile duct diseases, such as biliary strictures, biliary obstructions due to common bile duct stone, periampullary tumors, and Hemobilia.

Intervention(s)

Intervention1: SpyGlassâ?¢ Direct Visualization System (DVS): The SpyGlass Direct Visualization System is made up of the following devices:
SpyScopeâ?¢ Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
SpyGlassâ?¢ Direct Visualization Probe is intended to provide direct visualization for examination for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
SpyBiteâ?¢ Biopsy Forceps are indicated for tissue acquisition in the pancreaticobiliary system.
SpyGlassâ?¢ Capital Components are intended to deliver a video image.
NOTE: Although the SpyGlassâ?¢ DVS is indicated for use in cholangioscopy and in pancreatoscopy, this SpyGlass AMEA Registry will document only cholangioscopy cases.

Control Intervention1: As this is a single arm study, there is no comparator agent: As this is a single arem study, there is no comparator agent

Primary Outcome(s)

Procedural Success

1.Indeterminate strictures: 1) ability to visualize stricture or defect 2) ability to provide visual impression of malignancy 3) when applicable, ability to obtain SpyBite biopsy adequate for histology

2.Biliary stones cases: 1) ability to visualize stones 2) ability to successfully initiate stone fragmentation 3) ability to achieve stone clearance in one or more SpyGlass procedures.

3.Other Indications: ability to establish diagnosis and /or complete therapy

Timepoint: Procedure

Secondary Outcome(s)

11.For patients undergoing stone management: incidence of visualization of stones not suspected during previous ERCP.Timepoint: Procedure

6.For patients undergoing SpyBite biopsy: correlation between SpyGlass visual impression of malignancy and SpyBite histopathology.Timepoint: Up to 6 Months Post Procedure

8.For patients undergoing SpyBite biopsy: correlation between SpyBite histopathology and observed image features.Timepoint: Procedure

10.For patients undergoing stone management: correlation between stone size and ability to reach stone clearance in one SpyGlass session.Timepoint: Procedure

7.For patients undergoing SpyBite biopsy: diagnostic accuracy of SpyGlass visual impression of malignancy and SpyBite histopathology based on reported incidence of malignancy at 6 months of follow-up.Timepoint: Up to 6 Months Post Procedure

2.Impact of SpyGlass procedure on suspected diagnosis based on prior ERCP.Timepoint: Procedure

3.Impact of SpyGlass procedure on patient management.Timepoint: Procedure

5.For patients undergoing SpyBite biopsy: correlation between number of biopsies and conclusive histopathology of SpyBite biopsies.Timepoint: Up to 6 Months Post Procedure

1.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: 72 Hour Post Procedure Follow-up Visit

9.For patients undergoing stone management: number of SpyGlass procedures needed to reach stone clearance.Timepoint: Procedure

4.Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure.Timepoint: Up to 6 Months Post Procedure

Secondary ID(s)

90947376

Source(s) of Monetary Support

Boston Scientific Corporation

Ethics review

Status: Approved
Approval date: 27/09/2014
Contact:

Asian Institute of Gastroenterology

Status: Approved
Approval date: 20/10/2014
Contact:

Apollo Gleneagles Hospital IRB

Status: Approved
Approval date: 29/01/2015
Contact:

IEC, Global Hospitals, Mumbai

Status: Approved
Approval date: 31/03/2015
Contact:

Postgraduate Institute of Medical Education & Research IRB

Status: Approved
Approval date: 28/04/2015
Contact:

Medanta The Medicity

Results

• Date Completed: 28/02/2017