CompletedNot Applicable

Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)

Italy, Switzerland72 participantsStarted 2011-07

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed consent * Ages of 18 to 80 years. * Symptoms consistent with gallbladder disease including biliary colic or chronic right upper quadrant pain. * Ultrasound confirming gallstones Exclusion Criteria: * Acute cholecystitis * Biliary pancreatitis * Suspicion of common bile duct stones. * Pregnancy. * Previous upper abdominal open surgeries. * Severe lack of cooperation by patient due to psychological or severe systemic illness. * The presence of medical conditions contraindicating general anesthesia or standard surgical approaches. * Subject has a previous history of adverse reaction or allergy to ICG, iodine products (or excipient), shellfish or iodine dyes * Surgery converted to non-robotic procedures, such as open surgery or laparoscopic surgery

What they're measuring

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).

Timeframe: intra-operatively

Trial details

NCT IDNCT01410734

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12