Cholecystitis
Conditions
Brief summary
This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also providing a white light 360 degree images. The primary objective is to determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG: and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.
Interventions
DEVICEStryker1688 Fluorescence imaging system
The purpose of this study is to use SPY fluorescence imaging systems and indocyanine green (ICG) as a tool to determine the percentage of successful critical anatomy recognition and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.
Sponsors
Stryker Endoscopy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 years of age or older * Subject is scheduled to undergo laparoscopic cholecystectomy, elective or emergent * Subject provides informed consent and signs an approved informed consent document for the study * Subject is willing to comply with the protocol and study visit schedule
Exclusion criteria
* Subject is pregnant or lactating * Subject has a known allergy or history of adverse reaction to ICG, iodine or iodine dyes * Subject has known history of cholangitis, pancreatitis, prior bile duct injury, coagulopathy or known pre-existing liver disease * Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigation, interferes with the interpretation of study results, or integrity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome 1 | Intra-op visit | To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome 2 | Intra-op visit | To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging |
Other
| Measure | Time frame | Description |
|---|---|---|
| Outcome 3 | Post op follow- up (7-14 days) | To estimate the number of post-operative complications (related to gall bladder surgery |
Countries
United States
Outcome results
None listed