SpyGlass Direct Visualization System Clinical Registry in China

NCT02287194 | Completed

• 1 other identifier: E7101
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Procedural success rate

  1. 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 2. 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. 3. 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 Outcomes (1)

• Safety Endpoints

  Post Procedure

Study Arms (1)

SpyGlass Direct Visualization System

Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of biliary tract diseases.

Device: SpyGlass

Interventions

SpyGlass DEVICE

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.

SpyGlass Direct Visualization System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age above 18 and not above 85.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 17258991 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Zhaoshen Li, Prof.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: November 10, 2014
• Study Start: November 28, 2014
• Primary Completion: April 30, 2016
• Study Completion: December 31, 2017
• Last Updated: July 31, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)