Ignite Creation Date:
2024-05-06 @ 2:35 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02070068
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-02-19
Brief Title:
A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System During Laparoscopic Biliary and Hepatic Operations
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
A Pilot Study to Optimize Imaging When Utilizing the PINPOINT Endoscopic Fluorescence Imaging System for Identification of Biliary Anatomy During Laparoscopic Biliary and Hepatic Operations
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Operations on the liver bile ducts and gallbladders are some of the most commonly performed abdominal operations in the United States Cholecystectomy removal of the gallbladder is the most common of these with more than 750000 performed annually Injury to the common bile duct CBD during these procedures occur infrequently approximately 01 to 05 but it is an important source of patient morbidity Serious injuries often require at least one surgical repair and these repairs have variable long-term outcomes Techniques to allow the visualization of the bile ducts may prevent such an injury by providing vital information about the presence of gallstones in the CBD and show a surgical road map of the ducts Near-infrared NIR cholangiography has the advantage over standard cholangiography of not exposing patients and healthcare providers to radiation This technique also allows the superimposition of the cholangiogram onto the normal image
This study is being conducted to optimize an imaging technique called PINPOINT Images will be obtained during clinically necessary operations The images will be evaluated to determine the best method for locating and outlining the anatomy The information learned will guide the future use of PINPOINT in laparoscopic procedures
This study is being conducted to optimize an imaging technique called PINPOINT Images will be obtained during clinically necessary operations The images will be evaluated to determine the best method for locating and outlining the anatomy The information learned will guide the future use of PINPOINT in laparoscopic procedures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None