NCT02866045 - 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, Díez-Redondo P, Gil-Simón P, Herranz T, Pérez-Martín E, Ochoa C, Caro-Patón A
EUS-guided single-incision needle-knife biopsy: description and results of a new method for tissue sampling of subepithelial GI tumors (with video). Gastrointest Endosc. 2011 Sep;74(3):672-6. doi: 10.1016/j.gie.2011.05.042.
Mekky MA, Yamao K, Sawaki A, Mizuno N, Hara K, Nafeh MA, Osman AM, Koshikawa T, Yatabe Y, Bhatia V
Diagnostic utility of EUS-guided FNA in patients with gastric submucosal tumors. Gastrointest Endosc. 2010 May;71(6):913-9. doi: 10.1016/j.gie.2009.11.044. Epub 2010 Mar 11.

Endoscopic Ultrasonography Guided Fine Needle Biopsy (EUS-FNB) vs. Single-incision Needle-knife (SINK) Biopsy for Diagnosis of Upper Gastrointestinal Subepithelial Lesions

Details for clinical trial NCT02866045

Clinical trial NCT02866045 - References