Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding (HALT)

February 1, 2018 updated by: Cook Group Incorporated

Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding

The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

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, TSH 4B9
        • Royal Alexandra
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver Coastal Health
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Science Centre University of Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth Ii Health Sciences Centre
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Center
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital- Civic Campus and General Campus
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus MC University Medical Center
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Bradford, United Kingdom, BD96RJ
        • Bradford Teaching Hospital NHS Foundation
      • Nottingham, United Kingdom, NG 2UH
        • University of Nottingham

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bleeding peptic ulcer

Exclusion Criteria:

  • Patient is: < 18 years of age
  • Patient is unable to consent
  • Patient is contraindicated to undergo endoscopy
  • Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
  • Patient is pregnant or lactating
  • Patinet has an INR > 2.5

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemospray Treatment
Hemospray Kit
Device: Hemospray Kit
Hemostasis of Arterial GI Bleeding
Other Names:
  • Endoscopic Hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with further bleed
Time Frame: 72 Hours
72 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with initial hemostasis
Time Frame: At the conclusion of the index procedure
At the conclusion of the index procedure

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

December 1, 2011

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

May 29, 2017

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-017

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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Locations

3
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