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A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Test of SpyGlass device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpyGlass | Device | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are undergoing ERCP or ERCP/cholangioscopy for known or suspected pancreaticobiliary disease.
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Peetermans, PhD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94120 | United States | ||
| University of Colorado Hospital |
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Between November 27, 2006 and April 4, 2008 a total of 297 subjects were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Test of SpyGlass device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Test of SpyGlass device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | percent | During Procedure |
|
|
2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Test of SpyGlass device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent Migration | Hepatobiliary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Peetermans, PhD, Director Endoscopy Clinical | Boston Scientific Corporation | 508-683-4211 | peetermj@bsci.com |
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| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202-5253 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905-0001 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15123 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0001 | United States |
| Erasme Hospital - Belgium | Brussels | 1070 | Belgium |
| Bispebjerg Hospital, Denmark | København NV | 2400 | Denmark |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| Evangelisches Krankenhaus Dusseldorf | Düsseldorf | D-40217 | Germany |
| Policlinico Agostino Gemelli | Roma | 00161 | Italy |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 81 |
| 297 |
| 0 |
| 297 |
| Bacteremia | Infections and infestations |
|
| Escherichia Bacteremia | Infections and infestations |
|
| Sepsis | Infections and infestations |
|
| Bacterial Sepsis | Infections and infestations |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Heparin induced Thrombocytopenia | Blood and lymphatic system disorders |
|
| Atrial Fibrillation | Cardiac disorders |
|
| Septicemia | Infections and infestations |
|
| Ureteral Obstruction | Renal and urinary disorders | from ovarian cancer |
|
| Partial Small Bowel Obstruction | Gastrointestinal disorders | From Ovarian Cancer |
|
| Neutropenia | Blood and lymphatic system disorders |
|
| Urinary Tract Infection | Infections and infestations |
|
| Anemia | Blood and lymphatic system disorders |
|
| Bell's Palsy | Nervous system disorders |
|
| Deep Vein Thrombosis | Vascular disorders |
|
| Worsening of Left C5-6 Radiculopathy | Nervous system disorders |
|
| Fever | Infections and infestations |
|
| Cholangitis | Hepatobiliary disorders |
|
| End Stage Liver Disease | Hepatobiliary disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Carcinamatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Enterocutaneous Fistula | Gastrointestinal disorders |
|
| Perforation of Bile Duct | Hepatobiliary disorders | From ERCP guidewire. |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Elevated Liver Function Tests | Hepatobiliary disorders |
|
| Hepatitis C | Hepatobiliary disorders |
|
| Liver Transplant Rejection | Hepatobiliary disorders |
|
| Infection | Infections and infestations | Unknown Type |
|
| Progression of malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Fall | Injury, poisoning and procedural complications |
|
| Abdominal Aortic Aneurysm Repair with Stent Graft | Vascular disorders |
|
| Flank Pain | Musculoskeletal and connective tissue disorders |
|
| Pancreatitis | Hepatobiliary disorders |
|
| Bile Duct Resection due to Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Abdominal Distress | Gastrointestinal disorders |
|
| Unknown Cardiovascular Event | Cardiac disorders | resulting in death |
|
| Obstruction of Bile Duct | Hepatobiliary disorders |
|
| Transient Desaturation | Respiratory, thoracic and mediastinal disorders |
|
| Intestinal Perforation | Gastrointestinal disorders |
|
| Liver Abcess | Hepatobiliary disorders |
|
| Probable Ileus | Gastrointestinal disorders |
|
| Acute Renal Failure | Renal and urinary disorders |
|
| Diagnosis of Cancer of the Pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Pericarditis and effusion | Cardiac disorders |
|
| Liver Failure | Hepatobiliary disorders |
|
| Umbilical Hernia Repair | Musculoskeletal and connective tissue disorders |
|
| Duct of Luschka Biliary Leak with Extrahepatic Biliary Stricture | Hepatobiliary disorders |
|
| Hypotension | Vascular disorders |
|
| Biliary Stent Replacement | Hepatobiliary disorders |
|
| Esophageal Variceal Bleeding | Gastrointestinal disorders |
|
| Abdominal Distention | Gastrointestinal disorders |
|
| Hallucination | Psychiatric disorders |
|
| Choledocal Cyst | Hepatobiliary disorders |
|
| Delayed Return of Bowel Function | Gastrointestinal disorders |
|
| Biloma with Possible Superinfection | Infections and infestations |
|
| Post ERCP Nausea | Injury, poisoning and procedural complications |
|
| Intra-abdominal Hemorrhage Post Planned Surgical Intervention | Gastrointestinal disorders |
|
| Probable Acute Myocardial Infarction | Cardiac disorders |
|
| Inflammatory Syndrome | Immune system disorders |
|
| Cholecystitis | Hepatobiliary disorders |
|
| Dysfunction of Pancreatic Stent | Hepatobiliary disorders |
|
| Hospitalization for EUS and Abdominal Ultrasound | Gastrointestinal disorders |
|
| Hospitalization to Repeat ERCP & Continue Bile Duct Investigation | Hepatobiliary disorders |
|
| Constipation | Gastrointestinal disorders |
|
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