Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

Theodor Bilharz Research Institute

Status: Completed

Conditions: Variceal Hemorrhage

Treatments: Device: Hemospray

Study type: Interventional

Funder types: Other

Identifiers

NCT01783899

Hemospray Varices

Details and patient eligibility

About

The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• 18 Years and older
• Bleeding Esophageal and / or Gastric varices

Exclusion Criteria:

• Patient is: < 18 years of age
• Unable to consent
• Contraindicated to undergo endoscopy,
• Already hospitalized for another illness
• Pregnant or lactating
• Patients with altered post-surgical anatomy of the stomach
• Previously placed intrahepatic portosystemic shunt
• Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Hemospray

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hemospray Group

Experimental group

Description:

Hemospray device consists of a syringe containing the Hemospray powder (21 g per syringe), a delivery catheter that will be inserted into the working channel of the endoscope, and an introducer handle with a built-in carbon dioxide canister to propel the Hemospray powder out of the catheter. In addition to Hemospray device any other required endoscopic accessories can be used during the procedure.

Treatment:

Device: Hemospray