Biliary Tract Diseases Clinical Trial
Official title:
A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
| NCT number | NCT00751998 |
| Other study ID # | E7012 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2006 |
| Est. completion date | October 2009 |
| Verified date | July 2021 |
| Source | Boston Scientific Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
| Status | Completed |
| Enrollment | 297 |
| Est. completion date | October 2009 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Erasme Hospital - Belgium | Brussels | |
| Denmark | Bispebjerg Hospital, Denmark | Kobenhavn NV | |
| France | Hopital Edouard Herriot | Lyon, Cedex 03 | |
| Germany | Evangelisches Krankenhaus Dusseldorf | Dusseldorf | |
| Italy | Policlinico Agostino Gemelli | Roma | |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Indiana University Medical Center | Indianapolis | Indiana |
| United States | Columbia University Medical Center | New York | New York |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | California Pacific Medical Center | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States, Belgium, Denmark, France, Germany, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | During Procedure |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02971579 -
A Register on the Quality of ERCP and Training of Endoscopists in Italy
|
||
| Recruiting |
NCT02310230 -
An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy
|
N/A | |
| Not yet recruiting |
NCT01900938 -
Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP
|
N/A | |
| Completed |
NCT00370344 -
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
|
Phase 2/Phase 3 | |
| Suspended |
NCT04559867 -
Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial
|
N/A | |
| Enrolling by invitation |
NCT04572711 -
Prospective Evaluation of Biliary Tissue Sampling With ERCP
|
||
| Recruiting |
NCT01715220 -
Treatment of Suspected Cholelithiasis With Nitroglycerin
|
Phase 2 | |
| Not yet recruiting |
NCT06015074 -
Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP
|
N/A | |
| Recruiting |
NCT05249400 -
Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training
|
N/A | |
| Completed |
NCT02287194 -
SpyGlass Direct Visualization System Clinical Registry in China
|
||
| Active, not recruiting |
NCT03190343 -
Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases
|
||
| Withdrawn |
NCT00672698 -
Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery
|
N/A | |
| Completed |
NCT04604652 -
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
|
Phase 2 | |
| Completed |
NCT02353286 -
Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent
|
N/A | |
| Recruiting |
NCT03074708 -
Application of 3D Visualization and 3D Printing in the Hepatobiliary and Pancreatic Surgery
|
N/A | |
| Not yet recruiting |
NCT06276153 -
Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer
|
||
| Withdrawn |
NCT03678480 -
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
|
Phase 2 | |
| Completed |
NCT04115696 -
Biodegradable Stent Implantation in Biliary Benign Strictures.
|
||
| Recruiting |
NCT04391426 -
Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
|
||
| Completed |
NCT01350037 -
Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
|
Phase 4 |