Status:
COMPLETED
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
Lead Sponsor:
Intuitive Surgical
Collaborating Sponsors:
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
University Hospital, Geneva
Conditions:
Gallbladder Disease
Biliary Colic
Eligibility:
All Genders
18-80 years
Phase:
NA
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 bil...
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 Fl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01410734
Start Date
July 1 2011
End Date
December 1 2012
Last Update
December 20 2012
Active Locations (2)
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1
SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy, 15100
2
Hospital University Geneva
Geneva, Switzerland