Study of Hemospray for Lower Gastrointestinal Hemorrhage

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099435
• Other study ID #: 12-007
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: January 19, 2017
• Start date: January 2015
• Est. completion date: November 6, 2016

Study information

• Verified date: January 2017
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 6, 2016
• Est. primary completion date: November 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Angiodysplasia
• Colonic Diverticula
• Colonic Polyp
• Colonic Polyps
• Diverticulosis, Colonic
• Diverticulum
• Diverticulum, Colon
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• Hemospray
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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	Montreal General Hospital - McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of device related adverse events		30 days
Secondary	Percentage of recurrent bleeding that occurs outside the blood vessel		30 days
Secondary	Percentage of hemostasis of lower GI bleeds originating from multiple sources		30 days
Secondary	All cause mortality	Mortality within 30 days of index procedure	30 days