NCT01393067 - 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)

Kahaleh M, Behm B, Clarke BW, Brock A, Shami VM, De La Rue SA, Sundaram V, Tokar J, Adams RB, Yeaton P
Temporary placement of covered self-expandable metal stents in benign biliary strictures: a new paradigm? (with video). Gastrointest Endosc. 2008 Mar;67(3):446-54. doi: 10.1016/j.gie.2007.06.057.
Phillips MS, Bonatti H, Sauer BG, Smith L, Javaid M, Kahaleh M, Schmitt T
Elevated stricture rate following the use of fully covered self-expandable metal biliary stents for biliary leaks following liver transplantation. Endoscopy. 2011 Jun;43(6):512-7. doi: 10.1055/s-0030-1256389. Epub 2011 May 26.
Wang AY, Ellen K, Berg CL, Schmitt TM, Kahaleh M
Fully covered self-expandable metallic stents in the management of complex biliary leaks: preliminary data - a case series. Endoscopy. 2009 Sep;41(9):781-6. doi: 10.1055/s-0029-1215050. Epub 2009 Aug 19.

Comparison of Use of Covered, Self-expandable Metal Stents (cSEMS) and Non-expandable Plastic Stents (NEPS) in Temporary Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation

Details for clinical trial NCT01393067

Clinical trial NCT01393067 - References