Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

This study has been completed.

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: December 25, 2014

Last verified: December 2014

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

Resource links provided by NLM:

MedlinePlus related topics: Bleeding

U.S. FDA Resources

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.


Enrollment:	30
Study Start Date:	January 2013
Study Completion Date:	June 2014
Primary Completion Date:	December 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

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783899

Locations


Belgium
Erasme Hospital , ULB
Brussels, Belgium, 1070
Egypt
Theodor Bilharz Research Institute
Giza, Egypt, 12311

Sponsors and Collaborators

Theodor Bilharz Research Institute

Université Libre de Bruxelles

Investigators


Principal Investigator:	Mostafa Ibrahim, MD	Université Libre de Bruxelles

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ibrahim M, El-Mikkawy A, Mostafa I, Devière J. Endoscopic treatment of acute variceal hemorrhage by using hemostatic powder TC-325: a prospective pilot study. Gastrointest Endosc. 2013 Nov;78(5):769-73. doi: 10.1016/j.gie.2013.07.037.


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:	December 25, 2014
Health Authority:	Belgium: Ethics Committee

Additional relevant MeSH terms:


Hemorrhage Pathologic Processes Hemostatics Coagulants

ClinicalTrials.gov processed this record on September 27, 2016

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