Clinical Evaluation of Hemospray: Hemostasis of Active GI Lumincal Tract Bleeding (HALT)

Completed

Conditions: bleeding peptic ulcers
nonvariceal GI bleeding
10017959

Registration Number: NL-OMON39250

Lead Sponsor: William Cook Europe, ApS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

Patients require hemostasis for nonvariceal GI bleeding. Specifically, patients with actively bleeding peptic ulcer with a Forrest score of 1a or 1b (spurting or oozing).

Exclusion Criteria

• Patient is < 18 years of age
• Patient is unable or unwilling to provide written informed consent
• Patient is on a thienopyridine class antiplatelet agent (e.g., Clopidogrel, Ticlopidine and Prasugrel) which cannot be discontinued for the procedure and 72 hours post procedure
• Patient is pregnant or lactating
• Patient has uncorrected coagulopathy as determined by the physician
• Patient is contraindicated to undergo endoscopy
• Altered post surgical anatomy of the stomach (e.g., bariatric surgery)
• Patient has a previously placed intrahepatic portosystemic shunt
• Patient has an ASA class 5 (See Appendix D)
• Patients with gastrointestinal fistula (e.g., trachea-esophageal fistula, bronchio-esophageal fistula)
• Patient with suspected gastrointestinal perforation
• Patient has an INR > 2.5

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary effectiveness endpoint: Proportion of patients with further bleeds<br /><br>within 72hours<br /><br>of the index procedure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Proportion of patients with hemostasis at conclusion of index procedure<br /><br>(initial hemostasis)<br /><br>• Clinical success: initial hemostasis and no SAE within 72 hours of index<br /><br>procedure<br /><br>• Early recurrent bleed: recurrent bleeding within 72 hours of the application<br /><br>of Hemospray<br /><br>• Late recurrent bleed: recurrent bleed occurring 72 hours - 30 days<br /><br>• The incidence of serious adverse GI event within 30 days of the application<br /><br>of Hemospray<br /><br>• Incidence of serious adverse events within 30 days of the application of<br /><br>Hemospray<br /><br>• Incidence of mortality at 30 days</p><br>