Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding

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.

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Key information

Conditions

Bleeding Peptic Ulcers Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Hemorrhage Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Alexandra, Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hemospray Kit

Device

Hemostasis of Arterial GI Bleeding

Other names: Endoscopic Hemostasis

Primary outcomes

Proportion of patients with further bleed

Time frame: 72 Hours

Secondary outcomes

Proportion of patients with initial hemostasis

Time frame: At the conclusion of the index procedure

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding

Acronym: HALT

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2017
First posted: Mar 2, 2011
Registry last updated: Feb 5, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed