Clinical Evaluation of Hemospray: Hemostasis of Active GI Lumincal Tract Bleeding (HALT) - HALT (Hemostasis of Active GI Luminal Tract Bleeding)

William Cook Europe, ApS0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Patients require hemostasis for nonvariceal GI bleeding. Specifically, patients with actively bleeding peptic ulcer with a Forrest score of 1a or 1b (spurting or oozing).

•Patient is < 18 years of age
•Patient is unable or unwilling to provide written informed consent
•Patient is on a thienopyridine class antiplatelet agent (e.g., Clopidogrel, Ticlopidine and Prasugrel) which cannot be discontinued for the procedure and 72 hours post procedure
•Patient is pregnant or lactating
•Patient has uncorrected coagulopathy as determined by the physician
•Patient is contraindicated to undergo endoscopy
•Altered post surgical anatomy of the stomach (e.g., bariatric surgery)
•Patient has a previously placed intrahepatic portosystemic shunt
•Patient has an ASA class 5 (See Appendix D)
•Patients with gastrointestinal fistula (e.g., trachea-esophageal fistula, bronchio-esophageal fistula)
•Patient with suspected gastrointestinal perforation
•Patient has an INR > 2.5

发起方

William Cook Europe, ApS