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Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

This study is currently recruiting participants.
Verified February 2013 by Theodor Bilharz Research Institute
Sponsor:
Collaborator:
Université Libre de Bruxelles
Information provided by (Responsible Party):
Mostafa Ibrahim, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier:
NCT01783899
First received: February 1, 2013
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Variceal Hemorrhage
 Device: Hemospray

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

Further study details as provided by Theodor Bilharz Research Institute:

Primary Outcome Measures:
  • Safety [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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:
  • Effectiveness [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemospray Group

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.

 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783899

Contacts
Contact: Mostafa Ibrahim, MD 00201006107100 mostafa.ibrahim@me.com

Locations
Belgium
Erasme Hospital , ULB Not yet recruiting
Brussels, Belgium, 1070
Contact: Jacques , Deviere     003225553712     jacques.deviere@erasme.ulb.ac.be    
Sub-Investigator: Jacques Deviere, PhD            
Principal Investigator: Mostafa Ibrahim, MD            
Egypt
Theodor Bilharz Research Institute Recruiting
Giza, Egypt, 12311
Contact: Ibrahim Mostafa, PhD     00201222113466     ibrahimmostafa@egyptgastrohep.com    
Sub-Investigator: Ibrahim Mostafa, PhD            
Sub-Investigator: Ahmed El Mikkawy, MD            
Principal Investigator: Mostafa Ibrahim, MD            
Sponsors and Collaborators
Theodor Bilharz Research Institute
Université Libre de Bruxelles
Investigators
Principal Investigator: Mostafa Ibrahim, MD Université Libre de Bruxelles
  More Information

No publications provided

Responsible Party: Mostafa Ibrahim, Gastroenterologist, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT01783899     History of Changes
Other Study ID Numbers: Hemospray Varices
Study First Received: February 1, 2013
Last Updated: February 4, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013