Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
NCT ID: NCT01783899
Last Updated: 2014-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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 Criteria
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Inclusion Criteria
* Bleeding Esophageal and / or Gastric varices
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Université Libre de Bruxelles
OTHER
Theodor Bilharz Research Institute
OTHER
Responsible Party
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Mostafa Ibrahim
Gastroenterologist
Principal Investigators
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Mostafa Ibrahim, MD
Role: PRINCIPAL_INVESTIGATOR
Université Libre de Bruxelles
Locations
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Erasme Hospital , ULB
Brussels, , Belgium
Theodor Bilharz Research Institute
Giza, , Egypt
Countries
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References
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Ibrahim M, El-Mikkawy A, Mostafa I, Deviere 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.
Other Identifiers
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Hemospray Varices
Identifier Type: -
Identifier Source: org_study_id