SpyGlass Direct Visualization System Clinical Registry in China (SpyChina)

Boston Scientific

Status: Completed

Conditions: Biliary Tract Diseases

Treatments: Device: SpyGlass

Study type: Observational

Funder types: Industry

Identifiers

NCT02287194

E7101

Details and patient eligibility

About

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

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

197 participants in 1 patient group

SpyGlass Direct Visualization System

Description:

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

Treatment:

Device: SpyGlass