Spy II Clinical Registry

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Biliary Tract Diseases

Treatments: Device: SpyGlass

Study type: Observational

Funder types: Industry

Identifiers

NCT00751998

E7012

Details and patient eligibility

About

A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

Enrollment: 297 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female >= 18 years of age
• Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
• Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)

Exclusion criteria

• Subjects for whom endoscopic procedure are medically contraindicated
• Subjects for whom ERCP are medically contraindicated
• Subjects for whom medical condition warrants use of device outside of indication for use

Trial design

297 participants in 1 patient group

Arm 1

Description:

Test of SpyGlass device

Treatment:

Device: SpyGlass