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Study of Hemospray for Lower Gastrointestinal Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02099435
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.

Condition or disease Intervention/treatment
Colonic Diverticula Angiodysplasia Colonic Polyp Device: Hemospray

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)
Study Start Date : January 2015
Actual Primary Completion Date : November 6, 2016
Actual Study Completion Date : November 6, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hemospray to treat lower GI bleeds Device: Hemospray
The Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa.




Primary Outcome Measures :
  1. Percentage of device related adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Percentage of recurrent bleeding that occurs outside the blood vessel [ Time Frame: 30 days ]
  2. Percentage of hemostasis of lower GI bleeds originating from multiple sources [ Time Frame: 30 days ]
  3. All cause mortality [ Time Frame: 30 days ]
    Mortality within 30 days of index procedure



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
clinical sites
Criteria

Inclusion Criteria:

  • Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis

Exclusion Criteria:

  • Less than 19 years old
  • Unwilling or unable to sign and date the informed consent
  • Pregnant, lactating or planning to become pregnant within 30 days of the procedure
  • Contraindicated to undergo colonoscopy

Medical/Endoscopic Exclusion Criteria

  • Actual or suspected lower GI perforation or fistula
  • Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
  • Actual or suspected ischemic colitis or infectious colitis
  • Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified)
  • Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099435


Locations
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Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada
Canada, Quebec
Montreal General Hospital - McGill University
Montreal, Quebec, Canada
Sponsors and Collaborators
Cook Group Incorporated

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02099435    
Other Study ID Numbers: 12-007
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Keywords provided by Cook Group Incorporated:
Gastriointestinal
Lower gastriointestinal
Digestive
Hemostasis
Recurrent bleeding
Hemospray
Additional relevant MeSH terms:
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Diverticulum
Diverticulum, Colon
Gastrointestinal Hemorrhage
Diverticulosis, Colonic
Angiodysplasia
Hemorrhage
Colonic Polyps
Pathologic Processes
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Vascular Diseases
Cardiovascular Diseases
Colonic Diseases
Intestinal Diseases