Study of Hemospray for Lower Gastrointestinal Hemorrhage

Completed

• Conditions: Colonic Polyp; Colonic Diverticula; Angiodysplasia
• Interventions: Device: Hemospray

• Registration Number: NCT02099435
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-28
• Study Start: 2015-01
• Primary Completion: 2016-11-06
• Study Completion: 2016-11-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemospray to treat lower GI bleeds	Hemospray	-

Primary Outcome Measures

Name	Time	Method
Percentage of device related adverse events	30 days

Secondary Outcome Measures

Name	Time	Method
Percentage of hemostasis of lower GI bleeds originating from multiple sources	30 days
Percentage of recurrent bleeding that occurs outside the blood vessel	30 days
All cause mortality	30 days	Mortality within 30 days of index procedure

Trial Locations

Locations (4)

Montreal General Hospital - McGill University; 🇨🇦 Montreal, Quebec, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada