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

Primary Purpose

Bleeding Peptic Ulcers

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hemospray Kit
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Peptic Ulcers focused on measuring Endoscopic Hemostasis, Peptic Ulcer, Recurrent Bleeding, Injection Therapy, Thermal Probe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Alexandra
  • Vancouver Coastal Health
  • Health Science Centre University of Manitoba
  • Queen Elizabeth II Health Sciences Centre
  • London Health Sciences Center
  • The Ottawa Hospital- Civic Campus and General Campus
  • McGill University Health Center
  • Prince of Wales Hospital
  • Erasmus MC University Medical Center
  • Belfast City Hospital
  • Bradford Teaching Hospital NHS Foundation
  • University of Nottingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemospray Treatment

Arm Description

Hemospray Kit

Outcomes

Primary Outcome Measures

Proportion of patients with further bleed

Secondary Outcome Measures

Proportion of patients with initial hemostasis

Full Information

First Posted
February 17, 2011
Last Updated
February 1, 2018
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01306864
Brief Title
Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding
Acronym
HALT
Official Title
Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
May 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Peptic Ulcers
Keywords
Endoscopic Hemostasis, Peptic Ulcer, Recurrent Bleeding, Injection Therapy, Thermal Probe

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemospray Treatment
Arm Type
Experimental
Arm Description
Hemospray Kit
Intervention Type
Device
Intervention Name(s)
Hemospray Kit
Other Intervention Name(s)
Endoscopic Hemostasis
Intervention Description
Hemostasis of Arterial GI Bleeding
Primary Outcome Measure Information:
Title
Proportion of patients with further bleed
Time Frame
72 Hours
Secondary Outcome Measure Information:
Title
Proportion of patients with initial hemostasis
Time Frame
At the conclusion of the index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Alexandra
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
TSH 4B9
Country
Canada
Facility Name
Vancouver Coastal Health
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Health Science Centre University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
The Ottawa Hospital- Civic Campus and General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Erasmus MC University Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Bradford Teaching Hospital NHS Foundation
City
Bradford
ZIP/Postal Code
BD96RJ
Country
United Kingdom
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35124074
Citation
Sung JJY, Moreea S, Dhaliwal H, Moffatt DC, Ragunath K, Ponich T, Barkun AN, Kuipers EJ, Bailey R, Donnellan F, Wagner D, Sanborn K, Lau J. Use of topical mineral powder as monotherapy for treatment of active peptic ulcer bleeding. Gastrointest Endosc. 2022 Jul;96(1):28-35.e1. doi: 10.1016/j.gie.2022.01.020. Epub 2022 Feb 3.
Results Reference
derived

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Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

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