NCT02697149 - 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)

Liao C, Thosani N, Kothari S, Friedland S, Chen A, Banerjee S
Radiation exposure to patients during ERCP is significantly higher with low-volume endoscopists. Gastrointest Endosc. 2015 Feb;81(2):391-8.e1. doi: 10.1016/j.gie.2014.08.001. Epub 2014 Oct 5.
Uradomo LT, Goldberg EM, Darwin PE
Time-limited fluoroscopy to reduce radiation exposure during ERCP: a prospective randomized trial. Gastrointest Endosc. 2007 Jul;66(1):84-9.

The Effectiveness and Safety of Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II

Clinical trial NCT02697149 - References