Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

• ClinicalTrials.gov Identifier: NCT01783899
• Recruitment Status: Completed
• First Posted: February 5, 2013
• Last Update Posted: December 30, 2014
• Sponsor: Theodor Bilharz Research Institute
• Collaborator: Université Libre de Bruxelles
• Information provided by (Responsible Party): Mostafa Ibrahim, Theodor Bilharz Research Institute

Tracking Information

• First Submitted Date: February 1, 2013
• First Posted Date: February 5, 2013
• Last Update Posted Date: December 30, 2014
• Study Start Date: January 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 25, 2014): 30
• Original Estimated Enrollment (submitted: February 4, 2013): 10
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Egypt

Administrative Information

• NCT Number: NCT01783899
• Other Study ID Numbers: Hemospray Varices
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mostafa Ibrahim, Theodor Bilharz Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Theodor Bilharz Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Université Libre de Bruxelles

Investigators

• Principal Investigator: Mostafa Ibrahim, MD; Université Libre de Bruxelles

• PRS Account: Theodor Bilharz Research Institute
• Verification Date: December 2014