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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306864
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bleeding Peptic Ulcers Device: Hemospray Kit Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
Study Start Date : December 2011
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : May 29, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hemospray Treatment
Hemospray Kit
Device: Hemospray Kit
Hemostasis of Arterial GI Bleeding
Other Name: Endoscopic Hemostasis

Primary Outcome Measures :
  1. Proportion of patients with further bleed [ Time Frame: 72 Hours ]

Secondary Outcome Measures :
  1. Proportion of patients with initial hemostasis [ Time Frame: At the conclusion of the index procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306864

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

Responsible Party: Cook Group Incorporated Identifier: NCT01306864     History of Changes
Other Study ID Numbers: 10-017
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Cook Group Incorporated:
Endoscopic Hemostasis
Peptic Ulcer
Recurrent Bleeding
Injection Therapy
Thermal Probe

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers