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

This study is currently recruiting participants.
Verified August 2017 by Cook Group Incorporated
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306864
First Posted: March 2, 2011
Last Update Posted: August 22, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
February 17, 2011
March 2, 2011
August 22, 2017
December 2011
March 2019   (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
Interventional
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.
 
Recruiting
80
March 2019
March 2019   (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)
No
Contact: Julie Whitaker 765-463-7537 Julie.Whitaker@Cookmedical.com
Canada,   Hong Kong,   Netherlands,   United Kingdom
 
 
NCT01306864
10-017
Not Provided
Not Provided
Not Provided
Cook Group Incorporated
Cook Group Incorporated
Not Provided
Not Provided
Cook Group Incorporated
August 2017

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