SpyGlass Direct Visualization System Clinical Registry in China (SpyChina)

Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System Throughout China

To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice.

Prospective, Post market, Multi-center, Non-randomized Study

Study Overview

• Status: Completed
• Conditions: Biliary Tract Diseases
• Intervention / Treatment: Device: SpyGlass

Detailed Description

Patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure will join this study, totally 500 patients across 16 sites throughout China will participate in study. After SpyGlass operation, all patients will be followed for 72 hours to observe adverse events, and patients with indeterminate stricture or undefined filling defect indication with tissue sampling not yielding histopathology positive for malignancy and unresolved device and/or procedure related SAE at 72 Hours will continue to be followed up until 6 months. Finally, procedure success rate will be analyzed as primary endpoint, and SAEs and impact of patients management will be analyzed as secondary endpoint.

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients seen at an investigational site during the enrollment period

• Presenting with an indication for cholangioscopy, or
• Presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure.

Description

Inclusion Criteria:

1. Age above 18 and not above 85.
2. Willing and able to provide written informed consent to participate in the study.
3. Willing and able to comply with the study procedures.
4. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SpyGlass Direct Visualization System; Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of biliary tract diseases.	Device: SpyGlass; The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success rate	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; 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.; 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.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	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.	Post Procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Publications and helpful links

General Publications

• Chen YK. Preclinical characterization of the Spyglass peroral cholangiopancreatoscopy system for direct access, visualization, and biopsy. Gastrointest Endosc. 2007 Feb;65(2):303-11. doi: 10.1016/j.gie.2006.07.048.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2014
• Primary Completion (ACTUAL): April 30, 2016
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (ESTIMATE): November 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases
• Other Study ID Numbers: E7101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO