Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT01410734
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
Sponsor:
Intuitive Surgical
Organization:
Study Overview
Official Title:
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree
Status:
COMPLETED
Status Verified Date:
2012-12
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:
The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.
Detailed Description:
Up to 40 patients will be prospectively enrolled in this multi-centre (up to 5 centres) single arm study. After given consent, patients will undergo minimally invasive cholecystectomy with da Vinci Fluorescence Imaging using Indocynine green (ICG) and near infra-red light (NIR) to identify the surgically relevant anatomy of the biliary tree during this procedure.
Efficacy endpoints The efficacy of the da Vinci Fluorescence Imaging Vision System to identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct (CBD).
Safety endpoints To observe and report peri-operative safety outcomes, including but not limited to incidence of adverse events and allergic reactions (rare according to the current knowledge and applications). Safety endpoints will be met by affirming the safety profile of the procedure, compared to currently available literature.
Efficacy endpoints The efficacy of the da Vinci Fluorescence Imaging Vision System to identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct (CBD).
Safety endpoints To observe and report peri-operative safety outcomes, including but not limited to incidence of adverse events and allergic reactions (rare according to the current knowledge and applications). Safety endpoints will be met by affirming the safety profile of the procedure, compared to currently available literature.
Study Oversight
Has Oversight DMC:
True
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?: