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Business/strategic reasons and low accrual rate
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryker1688 Fluorescence imaging system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome 1 | To determine the percentage of successful critical anatomy recognition using intra-operative SPY fluorescence imaging and ICG in subjects undergoing laparoscopic cholecystectomy | Intra-op visit |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome 2 | To estimate the number of times a surgeon altered the surgical plan due to information identified/revealed by SPY fluorescence imaging | Intra-op visit |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome 3 | To estimate the number of post-operative complications (related to gall bladder surgery | Post op follow- up (7-14 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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