The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy (NCT01424215) | Clinical Trial Compass
CompletedNot Applicable
The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
United States100 participantsStarted 2011-01
Plain-language summary
The purpose of this study is to evaluate whether a fluorescent die and a special infrared camera can assist with the identification of the important structures during laparoscopic cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in less time and in a safer fashion than standard laparoscopic cholecystectomy.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is willing and able to provide an informed consent
* Subject is willing and able to comply with the study procedures
* Subject speaks English and is able to understand the study procedures
* A pregnancy test for women of childbearing potential prior to surgery
* Subject is scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
* Subject has uremia, serum creatinine \>2.5 mg/dl
* Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
* Subjects in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
* Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Subject is a pregnant or lactating female
* Subject is actively participating in another drug, biologic and/or device protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Operative Time
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 48hours