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

This study is currently recruiting participants.
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01306864
First received: February 17, 2011
Last updated: February 12, 2014
Last verified: February 2014

February 17, 2011
February 12, 2014
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
Interventional
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
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 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
Both
18 Years and older
No
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
 
NCT01306864
10-017
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Joseph Sung, MD Prince of Wales Hospital, Shatin, Hong Kong
Cook
February 2014

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