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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.
ClinicalTrials.gov Identifier: NCT01306864
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : February 5, 2018
Information provided by (Responsible Party):
Cook Group Incorporated

February 17, 2011
March 2, 2011
February 5, 2018
December 2011
April 30, 2017   (Final data collection date for primary outcome measure)
Proportion of patients with further bleed [ Time Frame: 72 Hours ]
Same as current
Complete list of historical versions of study NCT01306864 on ClinicalTrials.gov Archive Site
Proportion of patients with initial hemostasis [ Time Frame: At the conclusion of the index procedure ]
Same as current
Not Provided
Not Provided
Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding
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.
Not Provided
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bleeding Peptic Ulcers
Device: Hemospray Kit
Hemostasis of Arterial GI Bleeding
Other Name: Endoscopic Hemostasis
Experimental: Hemospray Treatment
Hemospray Kit
Intervention: Device: Hemospray Kit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 29, 2017
April 30, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   Hong Kong,   Netherlands,   United Kingdom
Not Provided
Not Provided
Not Provided
Cook Group Incorporated
Cook Group Incorporated
Not Provided
Not Provided
Cook Group Incorporated
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP