Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

Not Applicable

Completed

• Conditions: Variceal Hemorrhage
• Interventions: Device: Hemospray

• Registration Number: NCT01783899
• Lead Sponsor: Theodor Bilharz Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-05
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-25
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemospray Group	Hemospray	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.

Primary Outcome Measures

Name	Time	Method
Safety	24 hours	Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.

Secondary Outcome Measures

Name	Time	Method
Effectiveness	24 hours	Information on efficacy will be obtained by measurements the proportion of patients with acute (procedural) hemostasis, and the rate of recurrent bleeding within 72 hours of treatment.

Trial Locations

Locations (2)

Theodor Bilharz Research Institute; 🇪🇬 Giza, Egypt

Erasme Hospital , ULB; 🇧🇪 Brussels, Belgium