Biliary Tract Diseases
Conditions
Keywords
biliary, ERCP, cholangioscopy, pancreatic
Brief summary
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
Interventions
DEVICESpyGlass
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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | During Procedure |
Countries
Belgium, Denmark, France, Germany, Italy, United States
Participant flow
Recruitment details
Between November 27, 2006 and April 4, 2008 a total of 297 subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Test of SpyGlass device | 297 |
| Total | 297 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 11 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 140 Participants |
| Age, Categorical Between 18 and 65 years | 157 Participants |
| Age, Continuous | 62.9 years STANDARD_DEVIATION 16.2 |
| Region of Enrollment Belgium | 11 participants |
| Region of Enrollment Denmark | 10 participants |
| Region of Enrollment France | 15 participants |
| Region of Enrollment Germany | 26 participants |
| Region of Enrollment Italy | 11 participants |
| Region of Enrollment United States | 224 participants |
| Sex: Female, Male Female | 152 Participants |
| Sex: Female, Male Male | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 297 |
| serious Total, serious adverse events | 81 / 297 |
Outcome results
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.
Time frame: During Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | 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 |