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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01306864
First received: February 17, 2011
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Bleeding Peptic Ulcers
Device: Hemospray Kit

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Proportion of patients with further bleed [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with initial hemostasis [ Time Frame: At the conclusion of the index procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemospray Treatment
Hemospray Kit
Device: Hemospray Kit
Hemostasis of Arterial GI Bleeding
Other Name: Endoscopic Hemostasis

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306864

Contacts
Contact: Levi Kosta-Mikel 765-463-7537 lkostamikel@medinst.com
Contact: Malin Tygesen 45 202 325 75 Malin.tygesen@cookmedical.com

Locations
Canada, British Columbia
St. Paul's Hospital Withdrawn
Vancouver, British Columbia, Canada, V6Z 2K5
Vancouver Coastal Health Recruiting
Vancouver, British Columbia, Canada
Canada, Manitoba
Health Science Centre University of Manitoba Completed
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Terminated
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London Health Sciences Center Completed
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital- Civic Campus and General Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
St. Michael's Hospital Withdrawn
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
McGill University Health Center Completed
Montreal, Quebec, Canada, H3G 1A4
Hong Kong
Prince of Wales Hospital Completed
Hong Kong, Hong Kong
Netherlands
Erasmus MC University Medical Center Terminated
Rotterdam, Netherlands, 3015 CE
United Kingdom
Bradford Teaching Hospital NHS Foundation Recruiting
Bradford, United Kingdom, BD96RJ
Glasgow Royal Infirmary Withdrawn
Glasgow, United Kingdom, G4 0SF
University of Nottingham Recruiting
Nottingham, United Kingdom, NG 2UH
Sponsors and Collaborators
Cook
  More Information

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01306864     History of Changes
Other Study ID Numbers: 10-017 
Study First Received: February 17, 2011
Last Updated: February 9, 2016
Health Authority: Canada: Canadian Institutes of Health Research
European Union: European Medicines Agency

Keywords provided by Cook:
Endoscopic Hemostasis
Peptic Ulcer
Recurrent Bleeding
Injection Therapy
Thermal Probe

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Hemostatics
Phenobarbital
Coagulants
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on July 21, 2016