Study of Hemospray for Lower Gastrointestinal Hemorrhage

A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)

This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.

Inclusion Criteria:

• Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis

Exclusion Criteria:

• Less than 19 years old
• Unwilling or unable to sign and date the informed consent
• Pregnant, lactating or planning to become pregnant within 30 days of the procedure
• Contraindicated to undergo colonoscopy

Medical/Endoscopic Exclusion Criteria

• Actual or suspected lower GI perforation or fistula
• Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
• Actual or suspected ischemic colitis or infectious colitis
• Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified)
• Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)