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Completed

NCT Number: NCT02099435

Study of Hemospray for Lower Gastrointestinal Hemorrhage

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

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Key information

Conditions

Colonic Diverticula Angiodysplasia Cardiovascular Diseases Colonic Polyp Colonic Polyps Digestive System Diseases Diverticular Diseases Diverticulum Diverticulum, Colon Gastroenteritis Gastrointestinal Diseases Hemorrhage Intestinal Polyps Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Alexandra Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hemospray

Device

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 outcomes

  1. Percentage of device related adverse events

    Time frame: 30 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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