Clinical trial NCT02287194: SpyGlass Direct Visualization System Clinical Registry in China
Official title: Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System Throughout China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-11-10
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural success rate
timeFrame: 72 hours
Secondary outcomes:
measure: Safety Endpoints
timeFrame: Post Procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.