Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

Bleeding Peptic Ulcers Clinical Trial

— HALT  

Official title:

Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306864
• Other study ID #: 10-017
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: February 1, 2018
• Start date: December 2011
• Est. completion date: May 29, 2017

Study information

• Verified date: February 2018
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 29, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Peptic Ulcers
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage

Intervention

Device:
• Hemospray Kit
Hemostasis of Arterial GI Bleeding

Locations

Country	Name	City	State
Canada	Royal Alexandra	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	London Health Sciences Center	London	Ontario
Canada	McGill University Health Center	Montreal	Quebec
Canada	The Ottawa Hospital- Civic Campus and General Campus	Ottawa	Ontario
Canada	Vancouver Coastal Health	Vancouver	British Columbia
Canada	Health Science Centre University of Manitoba	Winnipeg	Manitoba
Hong Kong	Prince of Wales Hospital	Hong Kong
Netherlands	Erasmus MC University Medical Center	Rotterdam
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Bradford Teaching Hospital NHS Foundation	Bradford
United Kingdom	University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

Canada,  Hong Kong,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with further bleed		72 Hours
Secondary	Proportion of patients with initial hemostasis		At the conclusion of the index procedure