SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
Stopped early · Phase 1
Conditions studied: Cholecystitis
In brief
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.
Key facts
- Study ID
- NCT05006950
- Run by
- Stryker Endoscopy
- People needed
- 50
- Starts
- 2021-06-28
- Expected to finish
- 2022-09-07
- Last updated by the study team
- 2022-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Anne Arundel Medical Center — Annapolis, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.