NCT04228835 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Schols RM, Bouvy ND, van Dam RM, Masclee AA, Dejong CH, Stassen LP
Combined vascular and biliary fluorescence imaging in laparoscopic cholecystectomy. Surg Endosc. 2013 Dec;27(12):4511-7. doi: 10.1007/s00464-013-3100-7. Epub 2013 Jul 23.
van Dam DA, Ankersmit M, van de Ven P, van Rijswijk AS, Tuynman JB, Meijerink WJ
Comparing Near-Infrared Imaging with Indocyanine Green to Conventional Imaging During Laparoscopic Cholecystectomy: A Prospective Crossover Study. J Laparoendosc Adv Surg Tech A. 2015 Jun;25(6):486-92. doi: 10.1089/lap.2014.0248. Epub 2015 May 14.

Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy: Results From a Randomized Controlled Study in University Malaya Medical Centre

Details for clinical trial NCT04228835

Clinical trial NCT04228835 - References