Study of Hemospray for Lower Gastrointestinal Hemorrhage

Sponsor

Cook Group Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT02099435

Collaborator

(none)

Enrollment

Locations

22.2

Duration (Months)

12.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colonic Diverticula Angiodysplasia Colonic Polyp	Device: Hemospray

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Nov 6, 2016

Actual Study Completion Date :

Nov 6, 2016

Arms and Interventions

Arm	Intervention/Treatment
Hemospray to treat lower GI bleeds	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.

Arm

Intervention/Treatment

Hemospray to treat lower GI bleeds

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.

Outcome Measures

Primary Outcome Measures

Percentage of device related adverse events [30 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country
1	Royal Alexandra Hospital	Edmonton	Alberta	Canada
2	University of Alberta Hospital	Edmonton	Alberta	Canada
3	Hotel Dieu Hospital	Kingston	Ontario	Canada
4	Montreal General Hospital - McGill University	Montreal	Quebec	Canada