Study of Hemospray for Lower Gastrointestinal Hemorrhage

Cook Group

Status: Completed

Conditions: Colonic Diverticula; Colonic Polyp; Angiodysplasia

Treatments: Device: Hemospray

Study type: Observational

Funder types: Industry

Identifiers

NCT02099435

12-007

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

50 participants in 1 patient group

Hemospray to treat lower GI bleeds

Treatment:

Device: Hemospray