Study of Hemospray for Lower Gastrointestinal Hemorrhage

January 19, 2017 updated by: Cook Group Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • Ontario
      • Kingston, Ontario, Canada
        • Hotel Dieu Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal General Hospital - McGill University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

clinical sites

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of device related adverse events
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

November 6, 2016

Study Completion (Actual)

November 6, 2016

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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