Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
CompletedNot applicableNCT01410734
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Gallbladder Disease
- Biliary Colic
- Gallstones
- Interventions
- Drug: Indocyanine green (ICG)
- Sponsor
- Intuitive Surgical
- Collaborators
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria; University Hospital, Geneva
- Start date
- 2011-07
- Primary completion
- 2012-12
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy, Switzerland
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01410734