SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Stryker Endoscopy
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Outcome 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Outcome 1
Time Frame: 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 Outcomes
- Outcome 2(Intra-op visit)