Hemostasis of Active Gastrointestinal (GI) Luminal Tract Bleeding (HALT)

Cook Group

Status: Completed

Conditions: Bleeding Peptic Ulcers

Treatments: Device: Hemospray Kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306864

10-017

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Hemospray Treatment

Experimental group

Description:

Hemospray Kit

Treatment:

Device: Hemospray Kit