Gallstones Clinical Trial
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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