NCT02212717 - 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)

de la Serna-Higuera C, Pérez-Miranda M, Gil-Simón P, Ruiz-Zorrilla R, Diez-Redondo P, Alcaide N, Sancho-del Val L, Nuñez-Rodriguez H
EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent. Gastrointest Endosc. 2013 Feb;77(2):303-8. doi: 10.1016/j.gie.2012.09.021. Epub 2012 Dec 1.
Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F
Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc. 2012 Apr;75(4):870-6. doi: 10.1016/j.gie.2011.10.020. Epub 2012 Jan 31.
Teoh AY, Binmoeller KF, Lau JY
Single-step EUS-guided puncture and delivery of a lumen-apposing stent for gallbladder drainage using a novel cautery-tipped stent delivery system. Gastrointest Endosc. 2014 Dec;80(6):1171. doi: 10.1016/j.gie.2014.03.038. Epub 2014 May 13.

Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.

Details for clinical trial NCT02212717

Clinical trial NCT02212717 - References