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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Cook
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 17, 2011
Last updated: May 12, 2015
Last verified: May 2015

February 17, 2011
May 12, 2015
December 2011
March 2016   (final data collection date for primary outcome measure)
Proportion of patients with further bleed [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 decreased rate of further bleed when compared to standard of care.

Not Provided
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
March 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bleeding peptic ulcer

Exclusion Criteria:

  • Patient is: < 18 years of age, unable to consent, contraindicated to undergo endoscopy, already hospitalized for another illness, pregnant or lactating
  • Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
  • Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Hemospray
  • Patient is pregnant or lactating
  • Patinet has an INR > 2.5
18 Years and older
Contact: Travis Conley 765-463-7537 tconley@medinst.com
Contact: Malin Tygesen 45 202 325 75 Malin.tygesen@cookmedical.com
Canada,   Hong Kong,   Netherlands,   United Kingdom
Not Provided
Not Provided
Principal Investigator: Joseph Sung, MD Prince of Wales Hospital, Shatin, Hong Kong
May 2015

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