N/A
N=297
Spy II Clinical Registry
Biliary Tract Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00751998 ↗Enrolled (actual)
297
Serious AEs
27.3%
Results posted
Apr 2011
Primary outcome: Primary: Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal. — 89 percent
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SpyGlass (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal. |
89 | — |
Summary
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00751998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.