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

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

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.


Condition Intervention
Bleeding Peptic Ulcers
Device: Hemospray Kit

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemospray Treatment Device: Hemospray Kit
Hemostasis of Arterial GI Bleeding
Other Name: Endoscopic Hemostasis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: Travis Conley 765-463-7537 tconley@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
Contact: Fergal Donnellan, MD    604-875-5224    Fdonnellan77@hotmail.com   
Canada, Manitoba
Health Science Centre University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Dana Moffatt    204.235.3282    dmoffatt@sbgh.mb.ca   
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Terminated
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 4G5
Contact: Terry Ponich    519.667.6878    terry.ponich@lhsc.on.ca   
The Ottawa Hospital- Civic Campus and General Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Harinder Dhaliwal, MD    613-798-5555    hadhaliwal@toh.on.ca   
St. Michael's Hospital Completed
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
McGill University Health Center Withdrawn
Montreal, Quebec, Canada, H3G 1A4
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Joseph Sung, MD    852.2632.3132    joesung@cuhk.edu.hk   
Netherlands
Erasmus MC University Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Ernst Kuipers    31 10 703 4681    e.j.kuipers@erasmusmc.nl   
United Kingdom
Bradford Teaching Hospital NHS Foundation Recruiting
Bradford, United Kingdom, BD96RJ
Contact: Sulleman Moreea, MD    44 (0) 1 274 364 463      
Glasgow Royal Infirmary Withdrawn
Glasgow, United Kingdom, G4 0SF
University of Nottingham Recruiting
Nottingham, United Kingdom, NG 2UH
Contact: Krish Ragunath    0115 924 9924    k.ragunath@nottingham.ac.uk   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Joseph Sung, MD Prince of Wales Hospital, Shatin, Hong Kong
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01306864     History of Changes
Other Study ID Numbers: 10-017
Study First Received: February 17, 2011
Last Updated: July 17, 2014
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:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Hemorrhage
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Intestinal Diseases
Pathologic Processes
Stomach Diseases
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014