A Single Center, Prospective, Open-Label, Single-Arm Study To Evaluate The Safety And Efficacy Of The Resolv® Endoscopic Hemostat System In Achieving Acute Hemostasis In Adult Subjects Diagnosed With Non-Variceal Upper Gastrointestinal Bleeding.

Hemostasis LLC0 个研究点目标入组 61 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1. Clinically known/confirmed GI bleeding – non variceal UGIB with bleeding severity of Forrest 1b, such as, post EMR, ESD, , or tumor bleed
•2. Subject is 18-90 years old
•3. Subject or legally authorized representative provides written authorization and/or consent
•4. Subject can be followed up for at least 72 hours post-operatively and then at 30 days

•1. Subjects is <18 years old
•2. Subject (or legally authorized representative) is unwilling or unable to provide informed consent
•3. NSAIDs, anticoagulants and antiplatelet agents cannot be discontinued prior to and for at least 72 hours after endoscopy
•4. Subject is pregnant or lactating
•5. Hemodynamic instability (blood pressure <90/60mm Hg and or pulse >110/mt at the time of endoscopy
•6. Subject who has known hypersensitivity to potato starch
•7. Presence of vascular shunt
•8. Subject has Uncorrected coagulopathy
•9. Peptic ulcers previously treated with other modalities (less than a week prior to the study)
•10. Contraindications for endoscopy
•11. Known decompensated chronic liver disease

发起方