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NCT00751998 Clinical Trial

Spy II Clinical Registry

Biliary Tract Diseases Clinical Trial

Official title:
A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date July 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SpyGlass
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.

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Italy, 

Outcome
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
See also
  Status Clinical Trial Phase
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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
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
Not yet recruiting NCT06015074 - Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP N/A