NCT05728697 - 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)

Eilenberg M, Munda P, Stift J, Langer FB, Prager G, Trauner M, Staufer K
Accuracy of non-invasive liver stiffness measurement and steatosis quantification in patients with severe and morbid obesity. Hepatobiliary Surg Nutr. 2021 Oct;10(5):610-622. doi: 10.21037/hbsn-20-787.
Fluss R, Faraggi D, Reiser B
Estimation of the Youden Index and its associated cutoff point. Biom J. 2005 Aug;47(4):458-72. doi: 10.1002/bimj.200410135.
Myers RP, Pomier-Layrargues G, Kirsch R, Pollett A, Duarte-Rojo A, Wong D, Beaton M, Levstik M, Crotty P, Elkashab M
Feasibility and diagnostic performance of the FibroScan XL probe for liver stiffness measurement in overweight and obese patients. Hepatology. 2012 Jan;55(1):199-208. doi: 10.1002/hep.24624. Epub 2011 Nov 18.
Sumida Y, Nakajima A, Itoh Y
Limitations of liver biopsy and non-invasive diagnostic tests for the diagnosis of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. World J Gastroenterol. 2014 Jan 14;20(2):475-85. doi: 10.3748/wjg.v20.i2.475.
Xiao G, Zhu S, Xiao X, Yan L, Yang J, Wu G
Comparison of laboratory tests, ultrasound, or magnetic resonance elastography to detect fibrosis in patients with nonalcoholic fatty liver disease: A meta-analysis. Hepatology. 2017 Nov;66(5):1486-1501. doi: 10.1002/hep.29302. Epub 2017 Sep 26.

Endoscopic Ultrasound Shear Wave Elastography: A Novel Tool for Fibrosis Screening in Patient With Elevated Body Mass Index and Suspected Non-Alcoholic Fatty Liver Disease or Steatohepatitis

Details for clinical trial NCT05728697

Clinical trial NCT05728697 - References