Study of Hemospray for Lower Gastrointestinal Hemorrhage

• Hemospray (Device): The Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa.

Primary outcomes

• Percentage of device related adverse events [30 days]

Secondary outcomes

• Percentage of recurrent bleeding that occurs outside the blood vessel [30 days]
• Percentage of hemostasis of lower GI bleeds originating from multiple sources [30 days]
• All cause mortality [30 days]: Mortality within 30 days of index procedure

Sex: All, ages: 19 Years to any

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)

• Results publication: Hookey L, Barkun A, Sultanian R, Bailey R. Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy. Gastrointest Endosc. 2019 Apr;89(4):865-871. doi: 10.1016/j.gie.2018.10.029. Epub 2018 Oct 26. PMID 30612959