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Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01783899
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : December 30, 2014
Sponsor:
Collaborator:
Université Libre de Bruxelles
Information provided by (Responsible Party):
Mostafa Ibrahim, Theodor Bilharz Research Institute

Tracking Information
First Submitted Date  ICMJE February 1, 2013
First Posted Date  ICMJE February 5, 2013
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
Safety [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
Effectiveness [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
Official Title  ICMJE Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Variceal Hemorrhage
Intervention  ICMJE 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

Study Arms  ICMJE 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.

Intervention: Device: Hemospray
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 25, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2013)
10
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01783899
Other Study ID Numbers  ICMJE Hemospray Varices
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mostafa Ibrahim, Theodor Bilharz Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Theodor Bilharz Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Université Libre de Bruxelles
Investigators  ICMJE
Principal Investigator: Mostafa Ibrahim, MD Université Libre de Bruxelles
PRS Account Theodor Bilharz Research Institute
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP