Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding (HALT)
This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Cook
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01306864
First received: February 17, 2011
Last updated: March 8, 2013
Last verified: March 2013
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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 2014 |
| Estimated Primary Completion Date: | March 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306864
Contacts
| Contact: Travis Conley | 765-463-7537 | tconley@medinst.com |
Locations
| Canada, British Columbia | |
| St. Paul's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6Z 2K5 | |
| Contact: Robert Enns 604-688-6332 renns@interchange.ubc.ca | |
| 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 | Not yet 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 | Active, not recruiting |
| 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 | Not yet recruiting |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Contact: Harinder Dhaliwal, MD 613-798-5555 hadhaliwal@toh.on.ca | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Norman Marcon 416-864-3092 norman.marcon@utoronto.ca | |
| Canada, Quebec | |
| McGill University Health Center | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Contact: Alan Barkun 514.934.8309 alan.barkun@muhc.mcgill.ca | |
| 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 | Not yet recruiting |
| Bradford, United Kingdom, BD96RJ | |
| Contact: Sulleman Moreea, MD 44 (0) 1 274 364 463 | |
| Glasgow Royal Infirmary | Not yet recruiting |
| Glasgow, United Kingdom, G4 0SF | |
| Contact: John Morris, MD 44 141 211 4823 John.Morris@ggc.scot.nhs.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: | March 8, 2013 |
| 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 Ulcer Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Stomach Diseases Gastrointestinal Hemorrhage Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013