Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

Variceal Hemorrhage Clinical Trial

Official title:

Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783899
• Other study ID #: Hemospray Varices
• Status: Completed
• Phase: N/A
• First received: February 1, 2013
• Last updated: December 25, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: Theodor Bilharz Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Variceal Hemorrhage

Intervention

Device:
• Hemospray
Patients will be resuscitated as needed to achieve hemodynamic stability in preparation for endoscopy within 24 hours of hospital admission. once the bleeding point will be identified at endoscopy, the delivery catheter will be inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip. Hemospray will be then delivered in short spray bursts (for 1-2 seconds) until hemostasis was confirmed. Once bleeding was controlled , the bleeding site will be observed for 5 minutes under endoscopy. Oral food and fluid will be with held from the patient for 24 hours. Intravenous octreotide and esomeprazole will given for up to 24 hours. Patients will be closely monitored for signs of recurrent bleeding for 24 hours post procedure. Recurrent bleeding will be diagnosed any patient experiencing recurrent bleeding will treated according to the institutional standard of care

Locations

Country	Name	City	State
Belgium	Erasme Hospital , ULB	Brussels
Egypt	Theodor Bilharz Research Institute	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute	Université Libre de Bruxelles

Countries where clinical trial is conducted

Belgium,  Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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.	24 hours	Yes
Secondary	Effectiveness	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.	24 hours	No